a double-blind placebo-controlled study of the application ... varhope and... · 2. simple eeg...

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SCIO’s ability to increase Charge Stability and Redox Potential

A double-blind placebo-controlled study of the

application of the SCIO Universal

Electrophysiological Biofeedback System for

statistical evaluation of the SCIO’s ability to increase

Body Wellness after one 45-minute session written and edited by Desire' Dubounet Andrea Taflan, IMUNE IMUNE Press 2009

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Contents SCIO‟s ability to increase Charge Stability and ............................................................... 1

ABSTRACT ..................................................................................................................... 4 PURPOSE OF STUDY .................................................................................................... 4

STUDY INDICATION RATIONALE: STRESS REDUCTION ........................................... 4 THE SCIO AND STRESS REDUCTION.......................................................................... 5 VARHOPE and STRESS ................................................................................................. 6

Expectations ................................................................................................................ 8 STUDY DESIGN .............................................................................................................. 9

TREATMENT GROUPS ............................................................................................... 9 BLINDING AND TEST SITES .................................................................................... 10

SUBJECTS ................................................................................................................ 11 TREATMENT PROTOCOL ADMINISTRATION PROCEDURE .................................... 11

PRE-POST TREATMENT PHASE ............................................................................. 11 SUBJECT GROUP ASSIGNMENT ............................................................................ 14

TREATMENT PHASE ................................................................................................ 14 TREATMENT ADMINISTRATION PROTOCOL ........................................................ 14 TREATMENT PHASE MEASUREMENTS ................................................................. 16

POST-TREATMENT PHASE ..................................................................................... 17 STATISTICAL ANALYSIS ............................................................................................. 17

PRIMARY EFFICACY OUTCOME MEASURE .......................................................... 17 SECONDARY EFFICACY OUTCOME MEASURES ................................................. 19

Conclusions ................................................................................................................... 28

DEFINITIONS ............................................................................................................ 28

Authors and Date of Report. ........................................................................................ 31

APPENDIX B: ............................................................................................................... 34 BACKGROUND INFORMATION ON THE BIORESONANCE TECHNIQUE ............. 34 BACKGROUND INFORMATION ON THE BIORESONANCE TECHNIQUE ............. 35

APPENDIX C: .................................................................................................................. 37 QUALITY OF LIFE QUESTIONNIARE ....................................................................... 37

APPENDIX D: .................................................................................................................. 39

ENERGY INDEX FACTOR ........................................................................................ 39

APPENDIX E: .................................................................................................................. 41 STRENGTH TEST ..................................................................................................... 41

APPENDIX F: .................................................................................................................. 43

ANAEROBIC OXYGENATION TEST......................................................................... 43

APPENDIX G: .................................................................................................................. 45 FLEXIBILITY TEST .................................................................................................... 45

APPENDIX H: .................................................................................................................. 47 MEMORY TEST ......................................................................................................... 47

APPENDIX I: ................................................................................................................... 51

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pH TEST .................................................................................................................... 51

APPENDIX J: ................................................................................................................... 53 VARHOPE TEST ....................................................................................................... 53

APPENDIX K ................................................................................................................... 56 SCIO TREATMENT PROTOCOL .............................................................................. 56

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ABSTRACT In this study we evaluated over 200 patients in a double blind test of their body electric parameters, wellness and stress. the double blind study was conducted with medical staff, medical supervision in Budapest, Hungary, Timisoara, Romania, Seattle, Washington, USA, Paris, France, and Speyer, Germany. They measured life style patterns, wellness measures, stress inventory, and global body electrical factors known as the VARHOPE. Components of Voltage, Amperage, Resistance, Hydration, Oxidation, Proton and Electron pressure. These factors were measured before a treatment and right after a single 45 minute SCIO session. There were significant results achieved in the VARHOPE scores pointing to a change in the body electric. There were results in the wellness scores but of less statistical validity. This points to a longer term study to perhaps increase the effects in these areas.

PURPOSE OF STUDY The purpose of this clinical study is to determine the efficacy of the SCIO Universal Electrophysiological Biofeedback Systems (SCIO). The device is indicated for use as a universal electrophysiological biofeedback system. This includes the following Eight Universal Items:

1. Stress Reduction and Lifestyle Stressors Questionnaire; 2. Simple EEG [electroencephalography] brain wave stress reduction including Cranial

electrotherapy; 3. Three-pole ECG [electrocardiography] simple heart awareness stress reduction; 4. EMG [electromyography] simple reeducation of muscles; 5. GSR [galvanic skin response] and TVEP [transcutaneous voltammetric evoked

potential]; 6. Transcutaneous electro nerval stimulation for pain reduction; 7. Trauma or wound healing and electro-osmosis; 8. Global Voltammetric Charge Stability; and Redox Potential All of these combine to form a universal electrophysiological biofeedback system for the detection of stress and reduction of stress, and the treatment of muscular re-education from injury, muscle weakness or dystonia, pain (TENS [transcutaneous electro nerval stimulation]), trauma/wound healing, charge stability imbalance, redox potential and electrophysiological reactivity. It is the purpose of this study to challenge and measure the effects of item 8. Can the SCIO make a measureable difference in the VARHOPE scores of charge stability and Redox Potential in just one 45 minute session?

STUDY INDICATION RATIONALE: STRESS REDUCTION Stress is known to have many negative effects on multiple aspects of an individual‟s life. Stress can affect an individual‟s physical, cognitive, emotional and social well-being.

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Over-stressed individuals will typically feel overwhelmed and unable to cope with or manage their usual workload and responsibilities. They may often feel anxious, angry, irritable or tense, and experience difficulty with concentration, focus, productivity and memory. Individuals suffering from stress may feel more tired or have less energy than usual and may lack interest in activities that would normally be of interest and enjoyment, and begin to feel alone or isolated from people around them. Oversleeping or inability to sleep may occur as well as overeating or lack of appetite. Physically, over-stressed individuals may get headaches or stiffness/tension in the muscles, jaw or back. They may experience frequent upset stomachs, skin rashes, racing heartbeat or sweaty palms. Even more significantly, those with untreated stress can develop high blood pressure, irregular heart rhythms, damage to arteries and higher cholesterol levels. Eventually, these symptoms may extend to the development and progression of coronary artery disease (atherosclerosis) and even a weakened immune system. Worsening many of these direct physical ailments is the fact that individuals who are stressed often turn to harmful habits to reduce their stress, such as cigarette smoking, overeating, use of drugs or over-use of alcohol. All of these factors put the person at additional risk for physical impairment, including heart disease and stroke. The Benefits of Stress Reduction are in their simplest form, a reduction, and often even reversal, of the individual‟s physical, cognitive, emotional and social symptoms that result from being overstressed. Reducing stress can even take an individual one step further toward improved overall mental and physical health and well-being.

THE SCIO AND STRESS REDUCTION The SCIO is designed to correct the manifestation of stress and/or electro-stress patterns within the individual at the most primal of physiological levels. The device works on the theory that stress disrupts the inherent electromagnetic frequencies at which the body‟s cells, organs, etc. resonate and that by returning these frequencies to their natural state, the stress and any subsequent illness that occurred because of the disruption can be corrected. Studies have shown that people who are over-stressed produce different patterns of brain waves than do people who are not over-stressed, and that reversal of that stress, in particular through techniques such as biofeedback training that employ the individual in controlling their return to stress-free living, can result in the abnormal patterns becoming normal. The SCIO tunes into an individual‟s body‟s physiological stress levels so that this information can be used to control the physiology, and consequently affect a decrease in those stress levels, resulting in improved physical and emotional health.

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VARHOPE and STRESS

The above diagram shows a key little known fact of biology. The factors of the wave formations of people differ from person to person. The values shown are not perfect. The height of the curve is the Voltage. Voltage is easily calculated from the electro-potential readings coming from the harness skin contacts. The area under the curve is the Amperage. An incremental measure of variant amplifications gives us an Amperage correlate. Resistance is easily calculated by determining the resistance to flow of a known voltammetric signal. With Voltage and Resistance known with the Amperage correlate and an application of Ohms law (Volts equals Amps times Resistance) we can virtually calculate Amperage better.

Amperage is the amount of charged particles flowing and Voltage is the pressure behind the flow. Without Volts and Amps there is no life.

Proton and Electron pressure or the charge stability of the system affects the polarity and the resting potential. The slight changes in these electrical profiles can be measured.

As we measure the changing Volts and Amps we get inductance and capacitance virtual scores and this allows us to find a Hydration and Oxygenation index. As Amperage changes

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slightly with each breath, we get an Oxidation index from comparing max and min values. Electrical measures of Oxidation are well known in the literature. We need to observe several normal breaths to establish a Oxidation index during the Calibration procedure. Voltage changes observed during the Calibration process give us a Hydration index (based on the free proton effect).

Thus there are definitely electrical values of each patient at multiple globally placed electrodes that make up a VARHOPE profile. These factors are most often controlled by life style behaviors and stress. Slight regulatory balancing from the guided electro-stimulation of the SCIO can also make changes.

Early Volt-Ammetry research noted a connection of body Voltage with the catecholamines of the body, and Amperage to the indolamines. The catecholamines are the hormones associated with the adrenal system, our fight flight system. Hypoadrenia is epidemic in our stress filled society. Stress unmanaged is weakening our adrenals and lessening our body Voltage. The indolamines are brain hormones associated with love and other high brain function.

Resistance measured in Ohms is perhaps the greatest variant. Normal skin resistance is 40 to 50 thousand Ohms. Our normal of 100 is based on there being not too much or to little Resistance. Inflammation diseases will makes Resistance go down and conductance go up. Degenerative diseases will make Resistance go up and conductance down. This is well documented in the literature. There are other things that effect Resistance that must be ruled out. But as we pass a current thru a limb or quadrant a decreased Resistance will reflect possible inflammation and an increased Resistance possible degeneration. Soft tissue will respond to lower frequencies below 100 and the bone to frequencies of 300 to 600. There can be degeneration and inflammation in the same quadrant. But the cybernetic pulse is designed to systematically thru stimulation measure and re-stimulation produce a guided auto-focusing pulse to treat any aberrant electrical profile. This is the SCIO.

Volts times Amps is Power. This is measured in Watts. The Volt-Ammetric research showed that giving catecholamines such as adrenalin made voltage go up. Giving indolamines like serotonin made Amperage go up. When body the body Amperage falls to low it signals the end of life. Adrenalin is associated with fear and anger. Serotonin is associated with love. We see reports of a small 100 pound mother picking up a car to save her child. An act of love. We do not hear reports of her picking up a car to throw at her husband. So love with indolamines power Amperage are more powerful. Increasing the Amperage of a circuit is more effective in power than Voltage.

Glen Rein and others have reported seeing an increase of adrenalin with a stimulation of the body of a 500 Hz signal. Indolamines were found to increase with a 1000 hz signal. The SCIO system can act to increase low Voltage and Amperage thru electro-stimulation. There is much volt-ammetric research on the effects of certain frequencies on the parts or hormones of the body.

Electro-stimulation is shown to increase osmosis thereby freeing minerals to stabilize pH. Cranial Electro Stimulation (CES) is used for treating stress, insomnia, depression, etc. and the use of MENS is found to have positive effects on pain, wound and trauma treatment. Once a body is subjected to low pulsed micro-current therapy the benefits are manifest in many ways. But the greatest value is improving the body‟s resistance to stress. Stress and stressors are the cause of all disease.

The SCIO sends in a micro-current stimulation and measures response. We can determine if the body responds harmonically or positively or negatively to the stimulation by

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analyzing the response. Thus a guided cybernetic loop pulse can help to increase the effects of the electro-stimulation. The body can be improved electrically and all regulatory procedures in the body can be improved with an increased VARHOPE profile.

The charge stability or Proton Electron pressure pH is a measure of the relative amount of charged particles in a system. We measure this globally as a measure of the whole body. Acids accept electron since they have an excess of protons. Hence the HCl, HS, HN, or the H means hydrogen which is a proton. Bases donate electrons since they have an excess of negative charge.

Most of our patients (over 80%) are sick because they are extra acid from stress, diets of meat and potatoes. They need electrons. The SCIO can shift from a sine wave to a square wave. This supplies more electrons. The body electric can divert the electrons to where they are needed.

If the patient is more alkaline, a spike wave is designed to help siphon off the excess through the device ground. The micro-current system can assist in correcting pH irregularities.

An Alarm response to a signal is produced by an unnatural increase in voltage on all electrode points. Harmonic reaction show little reaction. And resonant reactions show positive. So we can monitor the body electric and let the system auto-focus the safe micro-current to help correct functions of VARHOPE. There are oscillation functions in the body such a brain wave, heart action, and muscles. The SCIO can help to stabilize regulation of these processes with electro-stimulation as well. it is well shown in the literature how electro-stimulation of the body can have beneficial effects in these areas. The SCIO simply uses a cybernetic biofeedback loop to sharpen the auto-focusing effects of the safe micro-current device.

Expectations Following completion of the treatment phase with the SCIO, it is anticipated that the subjects in the test group, relative to subjects in the control group, will show, where applicable, the following results to support the following indications for use. The Practice Effect can be measured by placebo comparison, where applicable. a) The Quality of Life Questionnaire (see Appendix C) should be completed by the

investigator. Patient should be asked to rate their stress on a scale of 1-10 where 10 is highly stressed and 1 equals no stress. Patient should rate any symptoms that they have. Patient should rate how they feel in general. Patient should state if they have pain, emotional trauma, or injury that causes discomfort. Expected results would be that the patient‟s responses show that they feel an improvement (meaning closer to “1”) on the scale of 1-10.

b) Energy Index Factor (see Appendix D) is found by taking blood pressure and resting heart rate measurements before and after one 45-minute session. .

a. right arm sitting, b. left arm sitting, c. patient stands and immediately measure left arm standing.

The normal Energy Index Factor is 14,000 (at 120 + 80 X 70 = 14,000) and patterns showing improvement towards this norm are expected.

c) Strength: see Appendix E for complete details on the Strength Test. Using a dynamometer

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to measure strength before and after. Measure in kilograms of pressure based on the reading and an increase in kilograms of pressure is expected.

d) Oxidation: see Appendix F for complete details on the Oxidation Test. Patient holds breaths and stands up and sits down as many times as possible, while holding breath, until he can‟t hold breathe any longer and must breath. The post treatment Oxidation test should be an increase in times patient is able to complete a stand-up and then sit-down pattern while holding breath.

e) Flexibility: see Appendix G for complete details on the Flexibility Test. a. Low back – patient does a stretch to the point of still being comfortable. b. Side to Side – patient does a stretch the point of still being comfortable. c. Neck – patient does a stretch the point of still being comfortable.

Expected results are that the patient will be more flexible in the post test measurement. f) Memory: see Appendix H for complete details on the Memory Test. Patient is asked to

repeat a random sequence of numbers to determine if their memory improves (meaning they can recall a longer sequence of numbers) in the post-test measurement.

g) pH: see Appendix I for complete details on the pH Test. Using a standard Over-The-Counter (OTC) Acidity-Alkalinity Test in which a urine sample is taken, expected results are that the patient will change towards alkalinity in the post-test compared to the pre-test.

h) VARHOPE Test: (see Appendix J) is part of the Treatment Session. VARHOPE readings, taking during the actual SCIO Treatment Session are measurements of the body‟s reactivity to show Charge Stability Imbalances and also Redox Potential. The measurements are broken down into two parts as follows:

a. where VARHO will increase within the scale 0-110; b. PE will stabilize. The ideal reading for P at 75 and E at 65. The readings should

go towards the norm showing stabilization. For subjects in the control group, it is expected that there will likely be an improvement of approximately 5% in measured variables. That is, subjects in the control group will likely report some of the positive changes listed above for test group subjects. However, on average, any positive change in post-treatment measures for control subjects is expected to occur to a significantly lesser degree than for subjects in the test group.

STUDY DESIGN

This study will be a double-blind, placebo-controlled, randomized clinical trial designed to demonstrate safety and effectiveness of the Maitreya Kft. SCIO.

TREATMENT GROUPS

There will be two subject groups in this clinical study, with as close as possible to an equal number of subjects assigned to each of the two groups, as follows: Test group: Subjects in the test group will receive the actual study treatment with an active, operational harness. Control group: Subjects in the control group will receive a „fake‟ study treatment with a placebo

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harness that does not contain any active electrodes. Apart from the distinction of whether or not the subject receives the study treatment with the true or placebo harness attached to the SCIO device, all subjects will adhere to all phases of the entire protocol design.

BLINDING AND TEST SITES

This clinical study will be a double-blind design, such that neither the subject nor the investigator will be aware of to which group a subject has been assigned (test or placebo) until after the clinical study is complete.

Each testing site will be given one piece of equipment - either a placebo equipment or an actual equipment. The Sponsor must ensure that where one site is given a placebo equipment another site is given an actual equipment, so that in the end there is the same number of Placebo Testing Sites as Actual Testing Site. Testing sites are chosen on the basis that the staff is knowledgeable of the functions of the device and are well trained and supervised to conduct the study. Either the Clinical Investigator or an Independent Monitor will supervise the study. Subjects assigned to Testing Site A will be treated with the SCIO device A using Harness A and subjects assigned to Testing Site B will be treated with the SCIO device B using Harness B. Only the study Sponsor will know which label („A‟ or „B‟) corresponds to the actual (test) device and harness and which label corresponds to the placebo device and harness until the study is complete. The Sponsor will ensure this information is stored and maintained confidentially at the Sponsor‟s work site. This knowledge will not be shared with the investigators, subjects, or study Monitor until the final subject data file of the study has been completed and submitted for analysis.

The placebo equipment will be designed to have the same external physical appearance as the actual equipment. The difference is that the placebo harness will not be equipped internally with functional electrodes and the programming for the placebo device will output only blank matrices. Neither the actual (test) nor the placebo harness produces any detectable noise, heat, light or other sensation output, so this also won‟t be a distinguishing factor for subjects or the investigator between the actual (test) and placebo devices.

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SUBJECTS

Sample size

There will be 40 subjects enrolled in this clinical study at each Testing Site. Testing will be done at different sites in different countries when possible.

TREATMENT PROTOCOL ADMINISTRATION PROCEDURE The recording of the study results should be both on paper and on computer (to ensure that if anything happens with the computer then the paper data is still available). The Case Report Forms are included in Appendix M. Additionally, under the following steps the computer based

information may be accessed and stored:

The software is written so that the test results can be stored in the software as well as documented on the Case Report Forms in Appendix M. To store the information on the software:

1. go to Retest in the top menu 2. click on Test VARHOPE Improvement 3. go to TOOLS 4. click on SCIO WELLNESS STUDY 5. do the Wellness Test and import the data on the pre-test and after completing the

treatment 6. click on Test VARHOPE Improvement 7. then return to TOOLS to enter the post-test numbers. 8. store and save report

PRE-POST TREATMENT PHASE The purpose of the pre-treatment phase is to record baseline measures against which post-treatment changes will be assessed, and to record demographic subject variables. The identical tests were performed post treatment and the data recorded. The following measures will be recorded during the pre-treatment administration phase: Physiological Measures 1. Blood Pressure: Systolic and diastolic blood pressure will be measured in millimeters of

mercury (mm Hg) using a sphygmomanometer. This should be taken a few minutes prior to the treatment and after the patient has been sitting comfortably for at least 1 minute.

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The subject‟s blood pressure reading will be classified as follows:

Category Systolic (mm Hg) Diastolic (mm Hg)

Normal less than 120 and less than 80

Prehypertension 120–139 or 80–89

Hypertension

Stage 1 140–159 or 90–99 Source: The Seventh Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure, American Heart Association.

N.B.: When a person's systolic and diastolic pressures fall into Different categories, the higher category is used to classify the blood pressure status.

2. Resting Heart Rate: Resting heart rate - the number of times your heart beats per minute -

will be measured at the wrist (radial artery), using the manual palpation method to feel the pulse. The precise methodology is detailed in the study qualification evaluation section.

The resting heart rate should be taken a few minutes prior to the treatment and after the patient has been sitting comfortably for at least 1 minute. If the subject‟s Resting Heart Rate average falls into the bradycardia, tachycardia or irregular categories (as defined Tachycardia: rapid or increased resting heart rate of greater than 100 beats per minute; Bradycardia: abnormally slow resting heart rate of less than 60 beats per minute; and Irregular Resting Heart Rate: Irregular pattern of beats wherein beats are consistently missed across a 60-second period) then it should be documented in the notes and the patient may continue with the study if they give Informed Consent.

Else, the subject‟s Resting Heart Rate will be recorded as the number of beats per minute.

A Resting Heart Rate in the range of 60 - 90 beats per minute is considered in the normal range. The average Resting Heart Rate for a male is 70 beats per minute, and for a female is 75 beats per minute.

Quality of Life Questionnaire

The responsibility is on the patient to determine what is their Quality of Life, and the investigator should not be guiding in suggestions by asking such questions as “Do you have a headache?” but should rather let the patient state, based on their own self-awareness state “I have a headache.” Based on this principle the following Quality of Life Assessment Measurements should be taken within 1 hour pre-test and within 1 hour post-test, but always as close to the test as possible. The Quality of Life Assessment Questions are included in the pre-test and post-test Quality of Life Questionnaire in Appendix C.

1. Patient should rate their stress on a scale of 1-10 where 10 is highly stressed and 1

equals no stress.

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2. Patient should rate any symptoms that they have on a scale of 1-10 where 10 means the symptom is highly unmanageable and 1 means the symptom is under control. (Symptoms need to come from the patient so that the patient is defining the issue).

3. Patient should rate how they feel in general where 10 is very bad and 1 is very good. 4. Patient should respond if they have pain and, if they do, then rate the pain. 5. Patient should respond if they have emotional trauma, and if yes, then rate the emotional

trauma. 6. Patient should respond if they have an injury which creates discomfort, and if yes, rate

the discomfort.

Body Wellness The following tests are performed pre-test. Listed here is the related Appendix where the protocol is found:

1. Quality of Life Questionnaire: Appendix C 2. Energy Index Factor: Appendix D (which is a result of the blood pressure and pulse

measurements and may be completed after the patient finishes). 3. Strength Test: Appendix E 4. Oxidation Test: Appendix F 5. Flexibility Test: Appendix G 6. Memory Test: Appendix H 7. pH Test: Appendix I

Demographic Variables

The following demographic variables will be recorded at the pre-treatment phase:

(i) Age (ii) Gender (iii) Race

Caucasian Hispanic Asian/Pacific Islander Middle Eastern Other

(iv) Education Level Less than high school High school Some college Undergraduate Graduate Post-graduate

Drug, Treatment and Food/Exercise Behavior and History The following drug and treatment history variables will be recorded at the pre-treatment phase:

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(i) Current medications – over-the-counter and prescription – that the subject is taking, including dosage schedule where possible.

(ii) Non-current medications – over-the-counter and prescription – that the subject has taken during the past 3 months.

(iii) Any herbs and dietary supplements that the subject is currently taken or has taken over the past 3 months.

(iv) All treatments in which the subject is currently engaged for any purpose. This includes conventional and alternative treatments and therapies. Alternative treatments and therapies include acupuncture, chiropractic, massage, etc. Any current treatment for the purpose of stress reduction will disqualify a subject from continued participation in the study and should have been screened during the study qualification evaluation phase.

(v) All treatments – conventional and alternative - in which the subject has partaken over the past 6 months for the purpose of stress reduction or relaxation.

(vi) Food/General Diet: Subject‟s general diet composition, such as typical average caloric intake, fat intake, vegetarian/non-vegetarian, etc.

(vii) Non-Alcoholic Drinks: General drink composition: number of glasses of water per day, fruit drinks, soda, milk, etc.

(viii) Alcoholic Drinks: Typical weekly alcohol consumption type and pattern, e.g. wine, beer, liquor, 2 glasses on a Saturday, one glass per day, none at all, etc.

(ix) Smoking: Yes or no; if yes, average number of cigarettes smoked daily. (x) Exercise: existent or not; type and general frequency.

SUBJECT GROUP ASSIGNMENT Subjects will be randomly assigned to testing site A or testing site B, as outlined in the STUDY DESIGN section above.

TREATMENT PHASE The treatment phase of the study will start the same day of the completion of the pre-treatment phase.

The study treatment phase will last 1 (one) 45-minute session and encompass 1 (one) treatment protocol. The entire time for study qualification evaluation, pre-testing, study treatment, and post-testing should take about 3 hours in total.

TREATMENT ADMINISTRATION PROTOCOL The most important aspect of the treatment protocol is the SOC (Suppression and Obstruction to Cure) panel. It includes the following questions that require a numerical response from the patient. Life style behaviors like smoking and not exercising are the most prolific causes of disease. By this interview we hope to increase awareness and encourage change in our

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patients. ____ Number of organs removed

____ Number of synthetic drugs used

____ Number of times you smoke or chew tobacco per day

____ Number of steroid type drugs used in the past

____ Current number of dental fillings that are NOT porcelain (including any removed within the

past year)

____ Number of street drugs used per month

____ Number of all known allergies

____ Number of unresolved mental factors

____ Responsibility for your disease on a scale of 0 (min) to 10 (max)

____ Amount of fat in your diet as a % of total calories (national average is 40%)

____ Personal stress level 0 (min) to 10 (max)

____ Number of sugar type products consumed per day (Including soft drinks, ice cream, etc.)

____ Number of exercise sessions per week, at 20 minutes or more per session (not work)

____ Number of alcoholic drinks consumed per day, on average

____ Number of cups of coffee, tea or caffeine products (including chocolate) consumed per day

____ Number of extreme toxic exposures per year (radiation, insecticide, chemicals,

chemotherapy, etc.)

____ Number of major injuries and surgeries (incl. emotional traumas) from past

____ Number of major infections

____ Number of water or natural fruit juice drinks per day

____ Number of pounds that you think you are overweight

Each treatment administration protocol will proceed as follows: 1. The subject is seated on a comfortable, non-metal chair in the treatment room.

2. The subject is connected to the SCIO harness system A or B according to group

assignment, with each electrode fixed to bare skin, as follows:

a. Red harness on right wrist. b. Yellow harness on left wrist.

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c. Blue harness on right ankle. d. Black harness on left ankle. e. Head harness on forehead with cord on right.

3. The investigator sets the SCIO device programming for the treatment protocol and goes through the SOC Panel to get the answers from the patient.

Details of the programming process and parameters are contained in Appendix K of this clinical study protocol document.

4. The subject remains seated and restful while the treatment protocol is administered. If the subject falls asleep they are permitted to sleep restfully as long as they don‟t make sudden movements which might pull the device off the table or unhook the harnesses.

5. When the protocol is completed, the investigator unhooks the harness from the subject. 6. The subject‟s treatment administration is complete.

7. The post-test measurements should be taken as soon as possible following the treatment

administration.

TREATMENT PHASE MEASUREMENTS

In following with the SCIO Treatment Protocol (see Appendix K), the investigator will document the VARHOPE at the beginning of the protocol and the VARHOPE reading at the end of the protocol will be recorded. The following measurements, using the tools and protocols established during the study qualification evaluation and pre-treatment assessment phases of the study, will occur after the treatment is completed.

Satisfaction with overall study outcome rating: The subject will be asked to indicate how satisfied he or she is with any overall change in perceived level of stress attained following the treatment administration period with the SCIO, using the following five-point scale:

Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied

Subject perceived group assignment: The subject will indicate whether he or she

believes to have been assigned to the treatment or placebo group, and why. Investigator perceived group assignment: The investigator will indicate whether he or

she believes the subject to have been assigned to the treatment or placebo group, and

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why.

At any time that is warranted: At any time that is warranted during the course of the study treatment administration phase, the subject and/or investigator may record the following:

Adverse Reactions and Events: Any belief or perception that the subject may have experienced an adverse reaction or event as a result of the treatment with the SCIO device. A subject adverse reactions and events sheet will be completed by the Principal Investigator. Any necessary action will be taken. More detailed information on this process can be found in the section below titled: “REPORTING OF ADVERSE REACTIONS AND EVENTS.”

Additional Comments: A subject or investigator may record any comments related to study participation at any time, as desired.

POST-TREATMENT PHASE The post-treatment phase will occur within 1 (one) hour after the treatment but as close to the treatment completion as possible. The purpose of the post-treatment assessment phase is to gain a sense of Body Wellness improvement after one treatment session.

STATISTICAL ANALYSIS

PRIMARY EFFICACY OUTCOME MEASURE Primary efficacy outcome measure for this clinical study will be a statistically significant difference in the proportion of subjects who demonstrate a change in total improvement between treatment and control group subjects, in favor of treatment group subjects. The measure will be evaluated in the following way: Subjects meeting Individual Success Criteria The individual subject success criteria is defined as a 5% improvement in measurable statistics. Overall Study Success Criteria. Overall study success criteria is defined as at least a 5% difference between groups, comparing the proportion of individual successes in each group. Evaluation Time Points The evaluation time point at which study success will be analyzed is after the treatment phase is completed for the final patient at each testing site.

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Null and Alternative Hypotheses For this clinical study: Null Treatment Hypothesis: There will be no statistically significant difference in the percentage of subjects in the Body Wellness Measures between subjects in the test and control groups. Alternative Treatment Hypothesis: There will be a statistically significant difference in the percentage of subjects who attain an improvement of 1% or more in the Body Wellness Measures following the treatment protocol with the SCIO between subjects in the test and control groups, in favor of test group subjects. Statistical Procedures Success of the study will be determined by simple calculation of the percentage of subjects in each treatment group who met the individual subject success criteria. If these percentages show that the overall study success criteria are met, the study will be considered to have had a successful outcome. In addition, the primary efficacy outcome measure will be evaluated in the following two ways: (i) Independent-Samples One-Tailed Z-Test of Proportions: This statistical procedure compares means for two groups of cases where the subjects have been randomly assigned to one of the two groups, so that any difference in response is due to the treatment (or lack of treatment) and not to other factors. A one-tailed z-test of proportions will be conducted to assess for a statistically significant difference in the average post-treatment Body Wellness scores for test versus control group subjects. (ii) Paired Samples T-Test: This procedure is a statistical test of the null hypothesis that two population means are equal. It is used when the observations for the two groups can be paired in some way, such as in this clinical study, when the same subject is observed before (pre treatment administration) and after (post treatment administration) a treatment. Pairing is used to make the two groups as similar as possible. Observed differences between the groups can then be attributed more readily to the variable of interest. Using the paired t-test, the percentage differences between the mean differences in final post-treatment Body Wellness score minus pre-treatment Body Wellness score for subjects in the test group versus subjects in the control group will be evaluated. For the primary outcome measure, two analyses will be performed: Intent-to-treat analysis (including all randomized patients), and Per-protocol analysis (subjects without major protocol deviations, incompletes excluded) Handling of missing data in the per-protocol analysis will be according to the multiple imputation

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method.

SECONDARY EFFICACY OUTCOME MEASURES The following secondary efficacy outcome measures will be evaluated using appropriate statistical techniques: a) An ANOVA will be used to evaluate the change in total Body Wellness score across the

measurement time points of pre-treatment and post-treatment, comparing test and control group subjects. It is expected that more test group subjects will demonstrate an improvement in Body Wellness in one or more tests from pre-treatment to treatment to post-treatment than will control group subjects.

a) Correlations between scores on the various inventories will be made. b) A z-test will be used to evaluate differences in outcome satisfaction ratings between test

and placebo group subjects. c) Evaluation of changes recorded on the VARHOPE readings during treatment will be made. d) Evaluation of comments provided by subjects will be made. e) Correlations between perceived and actual group assignments for both subjects and

investigators will be made. f) Safety outcome evaluation of any reported adverse events and reactions will be performed.

Analysis of results will be performed by individual test site and pooled across test sites. Application of a balanced test-control group study design incorporating a block by test site randomization procedure will contribute to statistical justification of pooling data across the different test sites. Results In our first study we went to Budapest , Hungary. Here there was significance in the VARHOPE scores an low back flexibility and urine pH.

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In our other test sites (Paris, Timisoara, Seattle, Speyer) there was significant results in the VARHOPE. There were four (4) testing sites under this study with the following number of subjects:

i. Timisoara (Romania): 38

ii. Seattle, Washington (USA): 40

iii. Paris (France): 40

iv. Speyer (Germany): 33

Total number of subjects for this study is 151.

There are interesting tendencies of the wellness data that sugest that maybe two or more sessions could make substantial wellness increases. The investigation was initiated on the 2nd of September 2009, in Timisoara, Romania, and completed on the 27th of November in Speyer, Germany. The total number of the subjects was 151. Out of the 151 patients that were eligible, 65 were randomly assigned to the Control Group, and 86 to the Treatment Group, as follows: Timisoara, Romania Control Group n=17 Treatment Group n=21

Seattle, Washington, U.S.A. Control Group n=20 Treatment Group n=20

Paris, France Control Group n=20 Treatment Group n=20

Speyer, Germany Control Group n=8 Treatment Group n=25.

The criteria for success was determined in the original, approved protocol as follows: “For subjects in the control group, it is expected that there will likely be an improvement of

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approximately 5% in measured variables. That is, subjects in the control group will likely report some of the positive changes listed above for test group subjects. However, on average, any positive change in post-treatment measures for control subjects is expected to occur to a significantly lesser degree than for subjects in the test group.” The results are as follows:

a. 86.90% of subjects had a V improvement of more than 5%,

b. 90.47% of subjects had an A improvement of more than 5%,

c. 88.09% of subjects had an R improvement of more than 5%,

d. 88.09% of subjects had an H improvement of more than 5%,

e. 89.28% of subjects had an O improvement of more than 5%,

f. 47.61% of subjects had a P improvement of more than 5%,

g. 48.80% of subjects had an E improvement of more than 5%.

Independent statisticians were contracted to review the data and it was determined that

statistical significance is p < 0.005, meaning that the significance of this data above is

acceptable.

Hypothesis#1 is therefore valid as shown by the high percentage of subjects who improved more

than 5% in the V, A and R Body Wellness indicators (reference a., b. and c. above).

Hypothesis#2 is therefore valid as shown by the high percentage of subjects who improved more

than 5% in the H and O Body Wellness Indicators (reference d. and e. above).

Hypothesis#3 is therefore valid as shown by the acceptable percentage of subjects who

improved more than 5% in the P and E Body Wellness Indicators (reference f. and g. above).

The other indicators of Body Wellness (Quality of Life Questionnaire, Energy Index Factor,

Strength, Anaerobic Oxygenation Test, Flexibility, Memory and pH) were not statistically

significant. This does not mean that the results are not valuable. A closer analysis shows that

there are trends in the improvement levels between the Test and Control (Placebo) group as

shown in Table 1.1 Percent of Subjects in each group who improved more than 5% in each of

the Body Wellness Indicators shown below:

Table 1.1. Percent of Subjects in each group who improved more than 5% in each of the Body

Wellness Indicators

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Test Control

(Placebo)

Left Hand 5.88% 9.23%

Right Hand 12.94% 13.84%

Anaerobic

Oxygenation Test

11.76% 7.69%

Flexibility Back 17.64% 26.15%

Flexibility Side 30.58% 30.76%

Flexibility Neck 31.76% 29.23%

Memory Forward 0.00% 0.00%

Memory Backward 1.17% 0.00%

pH 0.00% 0.00%

The following needs to be considered when reviewing this table:

1. Many investigators state that during a SCIO treatment most of their clients fall asleep and

take a small nap during the treatment (most likely a secondary benefit of the stress

reduction treatment).

2. Considering that many clients fall asleep, they might find their muscles more “stiff”,

therefore less flexible and/or strong, therefore yielding lower results for the Test group

(who fell asleep during the treatment) compared to the placebo group who did not fall

asleep. It should also be noted that in the Case Report Forms the investigator was

asked which group they felt the subject was assigned to and many responded based on

whether or not their subject fell asleep during the treatment.

3. A closer analysis shows that some subjects were already quite high in areas of Flexibility

and therefore could not realistically improve another 5% on top of their already high

measurements.

Therefore, a case-by-case analysis shows some trends in improvement where the subject needs

improvement in that area.

There were no special populations and therefore no sub-group necessary. Any missing data was left as a blank during the data analysis and therefore not used. Due to the short duration of the study, no patients withdrew during the study.

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Conclusions Considering the statistical significance of the results of the VARHOPE Scores, all three (3)

hypotheses are proven valid. Additionally, considering that there were no Adverse Events

during or following the study, the safety results of the study show that the device‟s performance

and safety validate the study objective. The benefits far outweigh the potential for any risks as

the subject‟s body wellness improves with one 45-minute treatment with the SCIO. There are

no other special precautions required for individual subjects

Suggestions for future studies include the following: 1. There is no need to take the blood pressure reading 3 times, as only the left arm sitting

(reading number 2) is used to calculate the Energy Index Factor. Furthermore, one blood pressure reading is sufficient to determine Inclusion/Exclusion criteria.

2. The field to enter the Quality of Life Questionnaire on the Case Report Notes should be revised to show the response to each question. For example, if a person responds that they are highly stressed in pre-treatment and then less stressed in post-treatment, then this can show a trend towards another Body Wellness measurement. The current fields on the Case Reports do not allow for the opportunity to analyze this data for trends.

3. There are some Body Wellness measurements that require more time to show trends or even significant changes, such as the pH measurement and the blood pressure measurement. Follow-up time and repeat treatments should be allowed if these measurements are to be used to substantiate the study results.

DEFINITIONS Detection of Stress and Reduction of Stress: meaning the device, will detect stress and help the body reduce its stress by stabilizing the body electric and increasing Body Wellness awareness. The Treatment of Muscular reeducation from Injury meaning the device, during the test will measure for electrical signs of muscular injury, the device will attempt to affect electrical repair of this injury and in the post-test we will re-measure to see if there are improvements in the patient‟s Body Wellness Measures. Patients in this study who report injury in pre-test questionnaire will be asked to evaluate the injury in the post questionnaire. So, this study should glean information about injured tissue repair that can either become statistically significant from this study or might point to a second study specifically on injured tissue. The Treatment of Muscular weakness or dystonia: meaning the device, during the test will measure for electrical signs of muscular weakness or dystonia, the device will attempt to affect electrical repair of this injury and in the post-test we will re-measure to see if there are improvements in the electrical parameters. Patients in this study who report muscular weakness in pre-test questionnaire will be asked to evaluate the injury in the post questionnaire. The Treatment of Pain; pain is only a verbal perception and can only be evaluated through

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verbal questionnaire. Meaning during the pre-test questionnaire the patient will inform of symptoms of pain on a scale of 0-10 and this will be evaluated during the post-test questionnaire for improvement of Body Wellness. The Treatment of Trauma/Wound Healing; see The Treatment of Pain and the Treatment of Muscular reeducation from Injury. Electrical stimulation has been shown to increase osmosis, known as electro-osmosis, and to stimulate the growth of new tissue in traumatized tissue. Our device applies a micro-current of electrical trauma repair. The Treatment of Charge Stability Imbalance; the Charge Stability is a balance of negative and positive ionic charges in the body. This is the acid-alkaline imbalance referred to in chemistry as pH. The body should be overall slightly alkaline meaning that there should be an excess of negative charge which is free electrons in the human body. We make an electrical, global measure of the charge then we can detect and affect and correct with the SCIO. The Treatment of Redox Potential; the O in VARHOPE stands for Oxygenation. As the body oxygenates, the amperage of the body surges. As the body discharges the oxygen, the amperage slightly dwindles. The difference in amperage over the respiration from maximum to minimum can tell us how well the oxygen works in the body and give us an indicator of the oxygenation. Electrostimulation of the osmotic and the Redox Potential can help to balance the body oxygenation and an improvement would be shown in Body Wellness #4, an improvement of oxidation measure in the post-test to the pre-test. The Measurement of Electrophysiological Reactivity (EPR); EPR is a measure of the change in volts plus change in amps plus change in resistance in a pre-test versus post-test of the body electric. This is known as reactance in an electrical system measured in Siemens. Aberrant reactive patterns to allergens, infectious organisms, or toxic reactions can be detected and affected and corrected by the SCIO. Body Wellness: For the purpose of this Clinical Study, Body Wellness is a term used to mean the following test and their results. The Body Wellness is taken pre-test and post-test and the tests are detailed in separate Appendices attached.

1. Quality of Life Questionnaire: questions of the patient‟s emotional state in which they are asked to rate their own pain, emotional trauma, or injury that causes discomfort.

2. Energy Index Factor: the result of an equation from blood pressure and pulse which offers a measurement of Energy Index.

3. Strength: a measurement of the patient‟s strength in one arm. 4. Oxidation: a measurement of the patient‟s ability to hold their breath while

performing a simple movement. 5. Flexibility: a measurement of the flexibility of the patient to the point of still being

comfortable while stretching. 6. Memory: a measurement of how well the patient can remember and repeat a

sequence. 7. pH Neutralization: a measurement of how well the patient changes towards a

more alkaline pH.

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Suppression and Obstruction to Cure (SOC): this is a Body Wellness lifestyle questionnaire that raises up awareness in clients, so they understand that in order to improve their health, they should make healthy lifestyle styles. This could give them their first idea that some of the things in their life, like alcohol or cigarettes, are damaging to their health. And also, they understand that in order to feel better, THEY should change.

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APPENDIX A:

Authors and Date of Report. Richard Lloyd, Regulatory Manager of Maitreya Kft. and Andreea Taflan, Monitor of the study

were the main authors, while Dr Rainer Mutschler, Principal Investigator of the study was the co-

author and grants approval of this Final Report.

The Head Investigator at each site is as follows and each signature is on the Cover Page of this

Final Report. (Note: electronic signatures are acceptable until such time that one original goes

around to all sites for original signatures). The original signed copy of the Final Report will be

maintained with the Sponsor.

Timisoara, Romania: Codruta Bacean

Seattle, Washington: Gage Tarrant

Paris, France: Jacqueline Jacques

Speyer, Germany: Dr. Rainer Mutschler The following Investigators were used in the following sites:

1. Timisoara (Romania):

a. Dr. Codruta Bacea, Head Investigator for this site

b. Dr. Onut Bacea

2. Seattle, Washington (USA):

a. Gage Tarrant, Head Investigator for this site

b. Bart Keough

c. Cindy Jones

d. Judy Steiner

3. Paris (France):

a. Jacqueline Jacques, Head Investigator for this site

b. Adrienne Muresan

c. Ann Priout

4. Speyer (Germany):

a. Katrin Sollner

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b. Andreea Taflan (who also worked as Monitor)

The following Volunteers were used in the following sites to take measurements:

1. Timisoara (Romania):

a. Dr. Onut Bacea

b. Dr. Codruta Bacea

2. Seattle, Washington (USA):

a. Jane Summers

b. Jill Caravalho

c. Gene Helton

d. Lynn Smith

e. Julie Cracker,

i. Additionally, the following two individuals helped in Seattle, Washington,

to ensure that Informed Consents were discussed and signed and

assigned subjects to random rooms for the treatment,

1. Christine Yamashita

2. Kathy Fry

3. Paris (France):

a. Jean-Pierre Turblin

b. Jacqueline Jacques

4. Speyer (Germany):

a. Katrin Sollner

b. Andreea Taflan (who also worked as Monitor)

The analysis of the data was completed by Zsofi Ret and Laszlo Agoszton, two independent,

unbiased experts in the field of statistics. They were hired to enter the data into Statistics SPSS

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and analyze the data with reports only on Significant or Non-Significant findings.

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APPENDIX B:

BACKGROUND INFORMATION ON THE BIORESONANCE TECHNIQUE

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BACKGROUND INFORMATION ON THE BIORESONANCE TECHNIQUE Edmund Jacobson first developed the progressive muscle relaxation technique. Although most of his research on the conditioning of muscle relaxation was conducted 50 years ago, it remains relevant today. For example, most therapeutic applications of biofeedback include the use of a systematic relaxation technique. Although Jacobson's system has been modified over time, his ideas and research methods have much to offer clinicians and researchers. Based on an interview reported by McGuigan, he may have been the first researcher to use medical instrumentation to provide feedback about physiological responses (Jacobson and McGuigan, 1978). His procedure, employing a prototype of modern biofeedback instrumentation, involved an individual observing an oscilloscope to determine the level of tension in his forearm extensor muscle. Later, Wolpe modified Jacobson's technique and popularized it as part of the systematic desensitization procedure. In 1958, Kamiya began to study the changes in consciousness that accompanied variations in EEG alpha rhythm of human subjects. He developed a discrimination conditioning task in which a bell was rung periodically and the subject was requested to indicate if he had been generating EEG alpha just prior to the auditory stimulus. Many subjects were able to learn this task and this led to further research of alpha rhythm control. Kamiya and his associates later discovered that subjects could suppress alpha when given auditory feedback concerning its presence or absence. One of the intriguing areas of investigation concerns the search for empirical validation of visceral or smooth-muscle operant conditioning. Neal Miller and his colleagues most notably, the late Leo DiCara, have been involved in research on instrumental autonomic conditioning in animals for a number of years. In 1968, DiCara and Miller observed that curarized rats could learn to avoid a shock by lowering their heart rate. Other investigators showed that visceral conditioning, through the use of feedback techniques, could be demonstrated in humans (Miller and Dworkin, 1974). Although less well known, H D Kimmel (1960) spent years investigating instrumental conditioning off the autonomic nervous system (ANS) in man. Stimulated by results of earlier experiments in conditioning of the galvanic skin response (GSR), Kimmel and his students found that subjects' GSR's could be conditioned using pleasant odors. Kimmel (1974) summarized the research up to 1967, including 16 studies of GSR, five of heart rate and three of the vasomotor response. Results of all these studies supported the contention that the ANS could be modified through operant conditioning. Subsequently biofeedback procedures were applied to clinical problems. In 1973, two innovative treatment procedures were developed which are widely used today, with certain technical refinements. Elmer and Alyce Green (1977) developed a clinical protocol for thermal feedback training. They used peripheral skin temperature as a measure of vasodilatation and combined skin temperature feedback with Schultz and Luthe's (1969) "Autogenic Training". Sargent, Green and Walters (1972) applied temperature biofeedback training to treat migraine. Patients were taught to increase the warmth in their fingers (vasodilatation) while decreasing the temperature of their foreheads (vasoconstriction). They found that almost 75 percent of the subjects were able to decrease both the duration and intensity of migraine attacks. Later studies have

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confirmed these results. While the Green's were developing their treatment technique for migraine, Thomas Budzynski (1973) and his associates at the University of Colorado developed a feedback technique to treat muscle contraction (tension) headaches. They used EMG training to teach patients to reduce the tension in their frontalis (forehead) muscles. Their results showed that average muscle tension levels dropped from 10 to 3.5 (microvolts) and headaches intensity was reduced over the 16-week training period. Two control groups of headache patients were employed in the experimental design; one group received "false" or pseudofeedback and the other group received no feedback at all. Neither of these groups improved as much as the EMG treatment group. The clinical research which has been reviewed thus far has involved procedures where feedback is used to reduce muscle and blood vessel contraction ("physiological arousal"); however, a technique to increase muscle contraction (a form of EMG biofeedback training) has existed for almost 25 years. John Basmajian's early research, first published in 1963, indicated that patients can increase the functioning of single motor units through the use of EMG biofeedback. Even earlier, Marinacci and Horande (1960) demonstrated that EMG feedback could be applied to improve neuromuscular functioning in several disorders. Basmajian and his colleagues have designed specially constructed biofeedback instruments for use in rehabilitation, e.g., a miniature EMG feedback device. They have applied such instrumentation to various disorders including paralytic foot-drop. There is significant difference between the EMG units used in rehabilitation and those adapted for use with psychophysiological disorders. The biofeedback units employed in rehabilitation are designed to transmit information about single motor units or the functioning of a specific muscle. Most of the EMG units used to enhance relaxation, however, summate the bioelectrical information of a particular muscle group. The resulting feedback is somewhat less specific. Prior to 1970, relatively few studies were conducted using biofeedback techniques. Since then, however, hundreds of investigations have been done and the accumulation of data has been impressive. For this reason, BSA task forces were developed to survey the current literature and summarize the current status of biofeedback as a therapeutic technique in a number of areas including: psychophysiological disorders (Fotopoulos and Sunderland, 1978), gastrointestinal disease (Whitehead, 1978), vasoconstrictive disorders (Taub and Stroebel, 1978), muscle tension headache (Budzynski, 1978) and others. In 1989, it was proposed and proved that biofeedback technique need not involve just a conscious or verbal process, but could work just as effectively at the subconscious level. The SCIO was designed to provide feedback to the individual‟s subconscious.

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APPENDIX C:

QUALITY OF LIFE QUESTIONNIARE

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Quality of Life Questionnaire: The investigator asks the patient the following questions. If more space is needed the investigator may use the back of this paper and must write “see back.” The Investigator explains that the rating is on a scale of 1-10, where 10 is more negative and 1 is more positive. Where appropriate, there are further explanations of the rating scale. The investigator is not to offer any further explanations but to stay to the following script.

“The following 6 questions are an opportunity for you to rate yourself. There is also a section on which you should decide what areas of concern you have. The questions form a Quality of Life Questionnaire and you will be asked to rate yourself again after the test. The rating is on a scale of 1 to 10 where 10 is more negative, painful, or difficult and 1 is more positive, without pain and easy. I must read the questions to you the way they are written. If they are not clear, then I can repeat them but I must repeat it again the way it is written. Rate yourself based on how you understand the questions. Let us begin.”

Please rate yourself on the following:

1. Rate your stress level where 10 is extremely stressed and 1 is slightly stressed. _________.

2. Rate how you feel in general where 10 is very bad an 1 is very good. ________. 3. Do you have pain? Circle one: Yes No If yes, rate your pain where 10 is

extremely painful and 1 is slightly painful ________. 4. Do you have emotional trauma? Circle one: Yes No If yes, rate your

trauma where 10 is extremely traumatic and 1 is slightly traumatic ___________. 5. Do you have an injury that causes discomfort? Circle one: Yes No If yes,

rate your injury where 10 is extremely uncomfortable and 1 is slightly uncomfortable _________.

6. Rate any symptoms you have that are of concern, where 10 means the symptom is highly unmanageable and 1 means the symptom is under control.

End of Quality of Life Questionnaire

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APPENDIX D:

ENERGY INDEX FACTOR

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The Energy Index Factor:

Left arm tends to be naturally higher than right arm in the systolic. Diastolic tends to be equal. The ideal blood pressure is 120/80. If there is a difference of 10 or more points from left arm to right arm in systolic, it indicates a cardiovascular problem with the heart. In the diastolic, a 5 point or more difference left to right arm, can indicate a dramatic cardiovascular disturbance. It is the adrenal gland that should boost the blood pressure when we stand and increase the height of blood fluid. Adrenaline kicks in so that we don‟t pass out. If the systolic blood pressure is 10 points or lower standing, it is a sign of hypo-adrenia. Differences between the systolic and diastolic in the arms sitting of more than 30 points, can indicate inter-cranial pressure. How to take the readings:

The blood pressure sitting is normal blood pressure, when the patient stands we immediately take the blood pressure in the left arm, and calculate the difference in the systolic and diastolic blood pressure. The Energy Index Factor formula Take the systolic left arm sitting + the diastolic left arm sitting x pulse = energy index factor.

Below 9,000 indicates parasympathetic control.

14,000 indicates balance.

18,000+ indicate sympathetic nerval control.

Expected Results It is our hope in our study that patients will move towards the normal patterns of blood pressure after treatment. This is the sign for improvement if the energy index factor improves.

End of Energy Index Factor

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APPENDIX E:

STRENGTH TEST

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Strength Test

Patient will complete a test with a hand-held Dynamometer once in each hand. Patient holds the Dynamometer in one hand. They give one big squeeze with one hand on the Dynamometer and the investigator documents how many kilograms of strength the patient was able to exert. The patient may not use their free hand to help exert more pressure with their hand around the Dynamometer. Document the reading. Reset the Kg reading on the left of the Dynamometer. Patient holds the Dynamometer in the other hand. They give one big squeeze with one hand on the Dynamometer and the investigator documents how many kilograms of strength the patient was able to exert. The patient may not use their free hand to help exert more pressure with their hand around the Dynamometer. Patient is not allowed to do the test again unless the Dynamometer accidentally falls out of their hand before they could finish the test. However, this must be documented by the investigator

End of Strength Test

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APPENDIX F:

ANAEROBIC OXYGENATION TEST

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Anaerobic Oxygenation Test During pre-test and post-test examination, the following Anaerobic Oxygenation Test should be performed.

1. Patient starts in a seated position, relaxed and at a normal breath rate for 1 minute. 2. The patient takes a deep breath at the same time that the investigator starts a stop-watch

counting minutes, seconds and tenths-of-a-second. 3. Patient stands up at a normal speed and sits down again at a normal speed while still

holding breath as long as possible. 4. As soon as patient stops holding breath and takes a new breath then investigator stops

the stop-watch. 5. Investigator must document the length of time that the patient held breath during

Anaerobic Oxygenation Test. The post treatment Anaerobic Oxidation Test should be an increase in time to hold breath showing test success.

End of Anaerobic Oxidation Test

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APPENDIX G:

FLEXIBILITY TEST

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Flexibility Test Success in flexibility of the muscle reeducation aspects of the test will show increases in the following Flexibility Test:

a. Low back – patient sits on the floor with legs stretched out in front, heels approximately 8 inches apart. The patient extends both hands, outstretched fingers towards their heels keeping legs straight. Patients are asked to do maximum stretch and touch the floor as far as they can, even going past the heels, if they can. The distance in inches from where their fingers touched the floor to the heels, with Zero at the heels, positive if they can extend past the heels, minus if they are before the heels. Normal scores are anywhere from -3 to 0, scores below -3 indicate low back difficulty. Ideal score should be 7 inches past the heels.

b. Side to Side – patient stands on their knees without bending forward or backward at the waste, they lean to the left side and try to touch their left palm to the floor. Touch their knuckles to the floor or try to touch their fingers to the floor and we measure the extent of their flexibility. Normal readings are touching fingers or knuckles to floor. An advanced patient will be able to touch their palm. If they cannot touch their fingers it indicates a lack of flexibility. A protractor is used to determine the angle of flexibility.

c. Neck – patient tries to touch their ear to their shoulder without raising their

shoulder to their ear. A protractor is used to determine the angle of flexibility.

End of Flexibility Test

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APPENDIX H:

MEMORY TEST

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Memory Test

An improvement in the number of digits the patient can recall frontwards and backwards will show improvement after the test. Most people can recall 7 numbers forwards and 5 numbers backwards. The Investigator follows these steps and documents the number of digits that the patient can recall forwards and backwards. The investigator is advised to chose a series of random digits and write them on a piece of scrap paper which should be kept with the patient‟s file. The suggested method is to chose the first set of random numbers. If the patient remembers these numbers in the proper sequence (either forward or backward depending on the memory test), then the investigator adds 2 to the existing digit and adds one more digit to the end to increase the sequence by one digit. This method should be continued until the end. The investigator should always write down the digit to ensure that they can reference the actual list when the patient repeats the digits. Forward Memory Test

1. The investigator explains, “I will now say a series of numbers in random order, for example 8 3 2. I will point to you when I finish the series and you will need to repeat the numbers in the same order. For example, you will repeat 8 3 2. When you complete the first repetition then I will begin again but this time adding one more number to the series. We will continue until you make a mistake or successfully repeat a series of 11 digits. The test begins now.”

2. The Investigator chooses a series of 5 random digits one at a time from 1-9, writes them down out of site of the patient, and repeats the series of digits at a normal speaking tone and pace.

3. The patient should repeat all numbers. 4. The investigator documents if they completed 5 digits forwards. 5. The Investigator adds 2 to each of the digits and adds one random digit at the end of the

sequence to make a series of 6 random digits. 6. The patient should repeat all numbers. 7. The investigator documents if they completed 6 digits forwards. 8. The Investigator adds 2 to each of the digits and adds one random digit at the end of the



sequence to make a series of 9 random digits. 15. The patient should repeat all numbers.

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16. The investigator documents if they completed 9 digits forwards. 17. The Investigator adds 2 to each of the digits and adds one random digit at the end of the


sequence to make a series of 11 random digits. 21. The patient should repeat all numbers. 22. The investigator documents if they completed more than 10 digits forwards and ends the

Forward Memory Test with this recording.

Backward Memory Test 1. The investigator explains, “I will now say a series of numbers in random order, for

example 8 3 2. I will point to you when I finish the series and you will need to repeat the numbers in the same order but this time backwards. For example, you will have to say 2 3 8. When you complete the first repetition then I will begin again but this time adding one more number to the series. We will continue until you make a mistake or successfully repeat a series of 11 digits. The test begins now.”

2. The Investigator chooses a series of 5 random digits one at a time from 1-9, writes them down out of site of the patient, and repeats the series of digits at a normal speaking tone and pace.

3. The patient should repeat all numbers backwards. 4. The investigator documents if they completed 5 digits backwards. 5. The Investigator adds 2 to each of the digits and adds one random digit at the end of the

sequence to make a series of 6 random digits. 6. The patient should repeat all numbers backwards. 7. The investigator documents if they completed 6 digits backwards. 8. The Investigator adds 2 to each of the digits and adds one random digit at the end of the





sequence to make a series of 11 random digits. 21. The patient should repeat all numbers backwards. 22. The investigator documents if they completed more than 10 digits backwards and ends

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the Backwards Memory Test with this recording.

End of Memory Test

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APPENDIX I:

pH TEST

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pH Test

An Over-The-Counter pH (acidity-alkalinity) Test Kit should be purchased and used for pre-test and post-test measurements. The Test Kit must meet the following criteria:

1. Be commonly available in a local drug store or pharmacy. 2. Be indicated for Over-The-Counter purchase and use. 3. Have sufficient stock so that the same brand, model number, or release number

of the Test Kit is used for all patients at the same Test Site (i.e. if 40 patients there must be 80 Test Kits [40 pre-test and 40 post-test] from Company “XYZ”‟s “Home pH Test Kit 2009”).

4. Have sufficient stock so that a new Test Kit is used for the every patient, every time, including pre-test and post-test measurements. Test Kits may not be re-used.

5. Be clearly labeled with easy Instructions for Use so that either the patient can administer their own test or an investigator‟s assistant can administer the test.

In following with the Instructions for Use, a clear reading should be obtained so that a measurement of any pre-test to post-test change may be noted. The pre-test reading should be taken within three (3) hours before the Treatment begins. The post-test may not be taken more than three (3) hours after the Treatment is completed. Water must be readily available so that patients could drink plenty of fluids to assist in giving a proper sample.

End of pH Test

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APPENDIX J:

VARHOPE TEST

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VARHOPE Test

We are made up of atoms that are mostly electrons and protons. The outer

electrons of any atom or molecule never touch. The outer electrons of any atom or molecule never touch another set of electrons. The entire interaction is through electro-magnetic-static, quantic, or other interactive fields.

There is Electrical energy in the human body. The most simple factors of anything electrical are the volts amps and resistance. This makes up Ohms law of electronics, where Volts = Amps x Resistance (that is Volts equals Amps times Resistance). This is a correlation not an exact law. Oscillations of the volts and amps give us the frequency of a current. Fluctuations of these calculations can be used in virtual or mathematical ways to calculate other biological factors. There are norms of the body electric variables relative to age and lifestyle. Thus the key Bio-electric factors of Volts Amps Resistance Hydration Oxidation and Proton versus Electron charge stability are measurable with the SCIO. The device then uses a cybernetic biofeedback loop which can help to stabilize the VARHOPE of a client. VARHOPE is an acronym coined by the manufacturer in which V = Voltage, A = Amperage, R = Resistance, H = Hydration, O = Oxygenation, P = Protons and E = electrons. The meaning of the VARHOPE numbers are separated into two (2) categories where VARHO is one category and PE and the second category. The VARHO readings are set on a scale, determined by the manufacturer, from 0-110. Changes in the readings are shown on the scale where an increase in number shows in improvement. The PE readings are set on a scale, determined by the manufacturer, where the closer the P reading to 75 the more the client‟s state of wellness has stabilized, and the closer the E reading to 65 the more the client‟s state of wellness has stabilized. For the purpose of this clinical study, the VARHOPE measurements are taken at the beginning of the test session with the SCIO and then again towards the end of the test session with the SCIO. The software is written so that the test results can be stored in the software.

8. go to Retest in the top menu

9. click on Test VARHOPE Improvement 10. go to TOOLS

11. click on SCIO WELLNESS STUDY

12. do the wellness test and import the data on the pre-test and after completing the treatment

13. Test VARHOPE Improvement

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14. then return to TOOLS to enter the post-test numbers.

End of VARHOPE Test

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APPENDIX K

SCIO TREATMENT PROTOCOL

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SCIO TREATMENT PROTOCOL

Be sure to have this document open on your computer before you start your day so you can access the codes and affirmation at the bottom of the document. These protocols will take approximately 1 hour to complete but may take longer depending on the comfort of the technician. Protocol

1. Greet client and bring them into your office 2. Have client sit on a non-metal chair and ensure that they are calm and relaxed. 3. Hook up client to harnesses with straps directly on bare skin. Remind patient that they

should not cross arms and legs. a. Red on right wrist b. Yellow on left wrist c. Blue on right ankle d. Black on left ankle e. Head harness on forehead with cord on right

4. Click on Clasp 32 Hands for entry to SCIO a. Close harness check box

5. Go to Password Enter 0210 and then click Ok 6. Go through Demographics with the client in the SOC panel, taking care not to engage in

too lengthy of a conversation, but to get direct answers – not being too strict but not being too loquacious.

7. Enter the button Enter Patient Data (Load New or Previous Patient) 8. Enter New Client

a. Type in first time only: i. Place in Birth date ii. Type in chief complaints in white box, iii. Address for geographic information of IRB/Ethics Committee report

9. Enter Birth Time and Place and then Geographic information. 10. Save Data and exit Client Data and Demographic pages 11. Enter Calibration Button. Calibration process should take 1-2 minutes. If calibration

process fails, patient should relax, have a class of water- after 10 minutes try again. Two failures means the patient cannot be calibrated today and they must try again a different day. After calibration proceed to the test. During these 3 minutes we do not talk directly to the patient. Don‟t talk about emotional issues – try to keep patient in the same emotional frame during the test.

a. Do the Computer Risk Field Neutralization b. Check Room For Geopathic Stress and clear if needed c. Fast Track Calibration d. Close to Main Page

12. Enter Test Matrix 13. Click Prepare Test and then Test 14. Record VARHOPE on case report for the Beginning of Session reading. 15. Test being complete, we review the test matrixes for the key items in the patient‟s health

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– this review should be approx 3 minutes. 16. Then proceed to the Risk Profile. We take the unconscious choice at the maximum of

the Risk Profile and we clear that using (using the link through the Risk Profile) a. Homotoxicology b. Spinal c. NLP d. Electroacupuncture e. Nutrition f. We chose one other area based on the patient‟s verbal concerns and clear that

area out with similar fashion. 17. We then proceed to the Therapy Screen to do at least one therapy, preferably the

therapy that the unconscious that the patient has selected. 18. After that, we put the patient on to a 10-15 minute biofeedback session. Ask the patient

to relax and the patient‟s subconscious will select the therapy. 19. The session is done – a couple of brief words of lifestyle suggestions as a debriefing

session – homework assignments, diet changes, exercise changes can be suggested. Foods to eat and foods to avoid – stress reduction techniques – all discussed at the debriefing session then the patient is ready for the post-test of Body Wellness measures.

a double-blind placebo-controlled study of the application ... varhope and... · 2. simple eeg...

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