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Clinical Review Criteria

External Neuromuscular Electrical Stimulator for Foot Drop (NESS L300),

Bioness Muscle Stimulator for Paralyzed Hands (NESS H200)Separate criteria exists for: Electrical Nerve Stimulators and WalkAide System for Patients with Foot Drop

Group Health Clinical Review Criteria are developed to assist in administering plan benefits. These criteria neither offer medical advice norguarantee coverage.Group Health reserves the exclusive right to modify, revoke, suspend or change any or all of these Review Criteria, atGroup Health's sole discretion, at any time, with or without notice. Member contracts differ in their benefits. Always consult the patient'sMedical Coverage Agreement or call Group Health Customer Service to determine coverage for a specific medical service.

CriteriaFor Medicare MembersSee NCD for Neuromuscular Electrical Stimulation (NMES) (160.12)

For Non-Medicare Members, see below.No criteria were developed at this time for Commercial Members. There is insufficient evidence in thepublished medical literature to show that this service/therapy is as safe as standard services/therapies(and/or) provides better long-term outcomes than current standard services/therapies.

The following information was used in the development of this document and is provided as backgroundonly. It is not to be used as coverage criteria. Please only refer to the criteria listed above for coveragedeterminations.

BackgroundFoot drop is a motor deficiency caused by partial or total paralysis of the muscles innervated by the

peroneal nerve. It is not a disease but a symptom of an underlying problem. It is often caused by aninjury to the peroneal nerve, but can also be associated with a variety of conditions such as stroke,dorsiflexor injuries, neuropathies, drug toxicities, or diabetes. The problem may be temporary orpermanent depending on the cause.

Foot drop is characterized by the lack of voluntary control of ankle dorsiflexion, and subtalar eversion.Patients with foot drop are unable to walk on their heel, flex their ankle, or walk with the normal heel-toepattern. They usually exhibit an exaggerated or high-steeping walk called steppage gait or footdrop gaitin order to compensate for toe drop. This unnatural walking motion may result in subsequent damageto the hip, back or knee (Voigt 2000).

Management of patients with foot drop varies and is dependent on the underlying cause. Some patients

may be fitted with of ankle-foot orthoses (AFO) brace, which typically limit ankle plantarflexion toenhance foot clearance during swing. Patients may also undergo physical therapy for gait training.Surgery may be an option when the cause of foot drop is muscular or neurologic.

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Electrical stimulation was first proposed as a treatment for foot drop by Liberson in 1961. Libersonreferred to the treatment as functional electrotherapy because its purpose was to replace a functionalmovement that was lost after injury or illness. There has been extensive development of functionalstimulation devices since the early 1960s. The first devices were hard-wired surface stimulators,followed by hard-wired implanted electrical stimulators, and then microprocessor-based surface andimplanted systems. In the 1990s, artificial and natural sensors were developed as a replacement for
http://www.ghc.org/all-sites/clinical/criteria/pdf/tens.pdfhttp://www.ghc.org/all-sites/clinical/criteria/pdf/walkaide2006.pdfhttp://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=160.12&ncd_version=2&basket=ncd%3A160%2E12%3A2%3ANeuromuscular+Electrical+Stimulaton+%28NMES%29http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=160.12&ncd_version=2&basket=ncd%3A160%2E12%3A2%3ANeuromuscular+Electrical+Stimulaton+%28NMES%29http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=160.12&ncd_version=2&basket=ncd%3A160%2E12%3A2%3ANeuromuscular+Electrical+Stimulaton+%28NMES%29http://www.ghc.org/all-sites/clinical/criteria/pdf/walkaide2006.pdfhttp://www.ghc.org/all-sites/clinical/criteria/pdf/tens.pdf


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the foot-switch. More recently, testing has been done on a device in which both the sensor andstimulator are implanted (Lyons et al. 2002).

The WalkAide system is an external neuromuscular functional stimulator. It contains a control unitattached to a flexible cuff that contains two electrodes. The unit is placed on the leg below the knee,near the head of the fibula. According to FDA materials, WalkAide stimulates the common peronealnerve which innervates the muscles that cause dorsiflexion of the ankle. This stimulation is intended toproduce a more natural and stable walking stride. It is indicated for individuals with foot drop due tocentral nervous system conditions including cerebral palsy, multiple sclerosis, traumatic brain injury,

and cerebrovascular accident. It is contraindicated for patients with traumatic accidents to the leg,complications of back, hip or knee surgery, sciatica, peripheral neuropathy, spinal stenosis, post-poliosyndrome and Guillain-Barre syndrome. In addition, patients with pacemakers or who experienceseizures should not use WalkAide (FDA materials; Innovative Neurotronics website). The InnovativeNeurotronics WalkAide System for foot drop was approved by the FDA in August, 2005 to address thelack of ankle dorsiflexion in patients who have experienced damage to upper motor neurons orpathways to the spinal cord.

The NESS L300 is another electrical stimulation system that received FDA clearance (in 2006) toprovide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury ordisease. It has the same intended use and same principal of operation as the WalkAide. The maintechnological difference however between the two systems, is the RF wireless communications

between the components of NESS L300 versus the wired communication in the WalkAide system.

NESS L300 is a neuroprothesis device that consists of four main parts 1. A lower leg orthosescontaining electrodes and a controlled stimulation unit, 2. A heel sensor 3. A control unit that is carriedin the pocket, mounted on the waist, or on a neck strap, and 4. PDA to be used by the clinician toconfigurate the control unit with functional parameters as appropriate for every patient. The system isintended to provide ankle dorsiflexion in individuals with foot drop following an upper motor neuroninjury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in theaffected leg to provide dorsiflexion of the foot. According to the manufacturer it may also facilitatemuscle reduction, prevent/retard disuse atrophy, maintain or increase joint range of motion andincrease local blood flow (FDA materials; Ness 300 website).

NESS H200 or Bioness is another new muscle stimulation device developed Bioness Inc. to restorefunction to paralyzed muscles. It is a brace like apparatus, equipped with electrodes to stimulate andactivate muscles that have been affected by stroke, injury, multiple sclerosis or cerebral palsy. The H200is worn on the forearm and hand, and holds the hand in a functional position. According to themanufacturer, the functional electrical stimulation is used to move affected areas through repetitiveexercises which would strengthen the muscles, reduce spasticity, improve blood flow, and increaserange of movement. A microprocessor allows the therapist to program the device with a sequence ofexercises customized to each patient. The system may be also used in the home setting (Bioness Inc.web page).

Stroke is one of the leading causes of disability and impairment in the United States. It is reported thatonly 12-18% stroke survivors will regain complete functional recovery of the upper extremity, and that

about 30% to 66% of those with paretic arms will still have an impaired upper limb function after sixmonths with routine rehabilitation. Arm dysfunction impairs the daily activities of the individual aswriting, dressing, bathing, self care, and in turn reduces the functional independence, occupationalperformance, and quality of life (de Kroon 2002, Meilink 2008, and Kwakkel 2008).

Loss of upper extremity function following stroke is a major rehabilitation challenge. Occupational andphysical therapies which are commonly used in the rehabilitation of stroke patients have not alwaysbeen satisfactory in improving the reaching, grasping, holding, or releasing functions of the paralyzedlimb. Investigators are now focusing on therapies that will lead to regaining and improving upperextremity functional activity rather than only minimizing the impairment (Alon 2008).


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Electrical stimulation (ES) has been studied and used clinically for about 40 years in differentneurological conditions such as cerebrovascular accidents, multiple sclerosis, cerebral palsy, and otherevents. Its use for the upper limb is getting increased attention as a therapeutic modality in poststrokerehabilitation. It provides continuous low voltage stimuli which enable repetitive exercise to theneuromuscular system. ES has two modalities: 1.Therapeutic electrical stimulation (TES) which applieshigher frequency (36 Hz) with the aim of activating the reduced muscle strength and preventing orlowering the pain and spasticity of the muscles, and 2. Functional electrical stimulation (FES) whichapplies lower frequency ES (18 HZ) in order to improve activity during the stimuli.

TES includes neuromuscular electrical stimulation (NMES), EMG-triggered electrical stimulation,positional feedback stimulation training (PFST), and transcutaneous electrical nerve stimulation(TENS). These have different indications, mechanisms of action, and are applied by multiple deviceswith a range of possibilities for the adjustment of stimulation parameter (Berner 2004, Kroon 2002).FES on the other hand, is the application of neuromuscular electrical stimulation concurrently with thetraining of task specific or functional activity i.e. provoking muscle contraction in order to assist theperformance of functional activities during stimulation. In the last decades, several research groupshave been working on the development of FES systems for the upper extremity, and currently multipledevices aiming at restoring the upper limb function are commercially available (Snoek 2000, Alon2008).

The NESS H200, formerly known as The Handmaster, (NESS Ltd Raanana, Israel) is a portable,non-invasive, hybrid wrist/hand orthosis and electrical stimulation device that is designed to be used inhemiplegic as well as C5 tetraplegic patients. It provides an instrument for both the treatment at thelevel of impairment (neuromuscular and articular properties) and disability (functional handgrip withstabilized wrist). The system contains an external control unit connected by a cable to a below theelbow splint. The splint contains a body with front spiral end and a wing which pivots about the bodyand can be opened by lifting a release handle. Five surface electrodes are attached to the splint andcorrespond with the motor points in finger and thumb muscles. The control unit allows the user to selectfrom among three exercise modes and three functional modes. The exercise modes provide stimulationto the targeted finger and thumb extensor and flexor muscles. The functional mode provides sequentialkey grip or palmer grasp and release patterns. The spiral design of the system allows wrist stabilizationin a functional position of 10 -20o of extension. The system is also designed to permit reproducible

accurate electrode positioning by the patient. Once fitted into the orthosis, the electrodes remain inposition for all subsequent applications and allow consistent replication of the grasp, hold and releasehand functions. The patient is provided with a progressive home exercise program and is required tofollow a conditioning paradigm using the systems exercise modes. Training periods start at 10 minutestwice daily and gradually increase to 45 minutes 2 times a day (Hara 2008, Snoek 2000).

The NESS system and the Handmaster device received FDA clearance in September 2002, andAugust 2003 respectively, to be used to maintain or increase the range of motion, reduce musclespasm, prevent retardation of disuse atrophy, muscle reduction, increase local blood circulation, andprovide hand active range of motion and function in patients suffering from upper limb paralysis due toC5 spinal cord injury, or hemiplegia due to stroke.

Evidence SummaryDate Epidemiologist Conclusion12/03/07 Nadia Salama,

MD, PhDThere is insufficient published evidence to determine the efficacy and safety of theNess L300 system for patients with foot drop.

There is insufficient published evidence to determine the efficacy and safety of theNess H200 system for the restoration of hand movements.

10/06/08 Nadia Salama,MD, PhD

The two published RCTs (Alon 2007, and Alon 2008) were conducted by thesame group of investigators in the same center, using the same eligibility criteria,procedures, and outcome measures. One of the studies (Alon 2007) included


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patients with mild/moderate paresis (Fugl- Meyer score 11-40), and the other (Alon2008) included patients with severe motor loss of the upper extremity (Fugl-Meyerscore 2-10). The two trials compared the standard physical and occupationaltherapies plus FES using NESS H200 versus the standard physical andoccupational therapies alone. The trials were small, unblinded, and had noextended follow-up after the end therapy. Their overall results showed someimprovement in movement and function in the patients randomized to the NESSH200. The observed differences vs. standard therapy were statistically significant inpatients with mild/moderate paresis but not in those with severe motor loss (Alon2008). The lack of statistical power in the latter study, as well as open-label design,short duration, and absence of follow-up do not allow making any definitiveconclusion regarding the effectiveness of the therapy or the persistence of theimprovements observed in patients with severe motor impairment.

Ring and colleagues trial (2005) was a comparative study with blindedassessment of outcomes, but had the disadvantage of inappropriate randomization,small number of patients, and absence of follow-up after the six weeks of therapy.The authors categorized the participants into those with or without active voluntarymotion of the fingers and wrist at baseline. Patients were assigned to receiverehabilitation with or without NESS Handmaster. The overall results of the trialshowed significant improvement in spasticity, motion, and function in all participantsreceiving the NESS Handmaster device vs. those who did not receive the device.The observed differences were statistically significant for all variables studies forpatients who had active partial range of movement at baseline. For those with no

active voluntary motion in the fingers and wrist at baseline, decrease in fingerspasticity was the only statistically significant improvement observed.Conclusion: There is poor evidence to determine that the use of NESS H200 may improveupper extremity function in patients with mild or moderate paresis/paralysis withsimilar eligibility criteria as those in the trials, compared to standard physical andoccupational therapies. There is insufficient evidence to determine whether the benefits observed wouldpersist after therapy is ended. There is insufficient published evidence to determine that the use of NESS H200would improve function in patients with severe motor loss in the upper extremity. There is insufficient published evidence to determine if the use of NESS H 200would lead to a faster motor and functional recovery vs. standard therapy alone.

There is fair evidence that NESS H200 is safe to use among patients with upperlimb impairment due to stroke, and who has eligibility criteria similar to those of thepublished studies.

Medical Technology Assessment Committee (MTAC) Recommendation12/03/07 The use of the NESS L300 or NESS H200 in the treatment of foot drop or paralyzed hands does not

meet the Group HealthMedical Technology Assessment Criteria.10/06/08 The use of the NESS H200 in the treatment of paralyzed hands does not meet the Group Health

Medical Technology Assessment Criteria.

Medical Director Clinical Review and Policy Committee12/17/07 The committee did not approve this device for coverage as there is insufficient evidence in the

published literature.

11/10/08 The committee did not approve Bioness NESS H200 (NESS Handmaster) for the upperextremity paralysis for coverage as there is insufficient evidence in the published literature.

Evidence/ Source Documents12/03/07 Literature search:1) Medline was searched to November 2007 with the search terms, foot drop, NESS L300,

Bioness, NESS H200 and electrical stimulation with variations.2) The search was limited to English language publications and human populations.


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3) The FDA website as well as the manufacturers page s were also examined for additionalinformation

12/03/07 Screening of articles:The search did not reveal any published studies, on Bioness, NESS L300, or NESS H200. Information about thedevices was obtained from the FDA and/or the manufacturers websites.

10/06/08 Literature search:1) Medline was searched through August 2008 using the terms: NESS H200, Handmaster, electrical stimulation,

functional electrical stimulation, Upper extremity, and paralysis with variations.2) The search was limited to English language publications and human populations.3) The FDA website and the manufacturers website were also examined for additional information.

10/06/08 Screening of articles:The search revealed a large number of published articles on the use of FES in general, but very limitedpublications on use the use NESS H200 ( NESS Handmaster) for patients with cervical spinal cord injury orstroke. The majority of studies on NESS H200 were case reports or case series with less than 30 patients. Therewere two small (N=15, and N= 26) randomized controlled trials and one quasi-randomized study, that comparedthe outcomes of FES using NESS H200 or NESS Handmaster devices in addition to the standard rehabilitationvs. standard rehabilitation alone in stroke survivors with impaired upper extremity. All three were criticallyappraised.

Alon G, Levitt AF, McCarthy PA. Functional electrical stimulation (FES) may modify the poor prognosis of stroke

survivors with severe motor loss of the upper extremity. Am J Rehabil Med 2008;87:627-636 SeeEvidence Table

Authors ConclusionsThe authors concluded that the addition FES to the exercises used in the study are likely to minimizemotor loss, but may not significantly enhance the ability to use the upper limb after an ischemic stroke.They also concluded that patients with severe motor loss may need prolonged task specific FES training.

Reviewers ConclusionsThe study had the advantage of comparing the functional electrical stimulation using NESSH200 in addition to the standard therapy vs. standard therapy alone. However the study was too small,had insufficient power to detect statistically significant differences between the study groups, the trial wasnot blinded, and the compliance of the patients to therapy was not monitored. Moreover, the duration ofthe study was only 12 weeks which may be insufficient duration of recovery for some patients, and too

short to determine the long-term duration of the improvement observed among some patients.

Alon G, Levitt AF, McCarthy PA. Functional electrical stimulation enhancement of upper extremity functionalrecovery during stroke rehabilitation: A pilot study. Neurorehabil Neural Repair 2007;21:207-215 SeeEvidenceTable

Authors ConclusionsThe authors concluded patients with mild /moderate paresis in the upper extremity who begin early task-oriented training together with FES may have better functional recovery than those who receive taskoriented training alone.

Reviewers ConclusionsThe study had the advantage of comparing the functional electrical stimulation using Ness H200 in

addition to task-oriented training vs. task-oriented training alone. However, it was too small, unblinded,and was conducted among a selected group of patients with more favorable prognosis. Moreover, andthe compliance of the patients to therapy was not monitored, and the study had no extended follow-upafter the end of therapy to determine the durability of the improvement observed.

Ring H, and Nechama Rosenthal. Controlled study of neuroprosthetic functional electrical stimulation in sub-acutepost-stroke rehabilitation. J Rehabil Med 2005;37:32-36 SeeEvidence Table

Authors Conclusions
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The authors concluded that the addition of daily home neuroprosthetic activation to the standardoutpatient rehabilitation improves upper limb outcomes.

Reviewers ConclusionsThe study had the advantage of comparing the functional electrical stimulation using Handmaster inaddition to the standard therapy to standard therapy alone; however the study was too small, hadinappropriate randomization, and no extended follow-up to determine if the improvement observed wouldpersist.

12/03/07 Additional references:Lyons GM et al. A review of portable FES-based neural orthoses for the correction of foot drop. IEEE TransNeural Syst Rehabil Eng 2002; 10: 260-279.

Voigt M and T Sinkjaer. Kinetics and kinetic analysis of the walking pattern in hemiplegic patients with foot dropusing a peroneal nerve stimulator. Clin Biomech 2000;15:340-351.

10/06/08 Additional references:Berner YN, Kimchi OL, Spokoiny V, et al. The effect of electric stimulation on the functional rehabilitation of acutegeriatric patients with stroke. A preliminary study. Arch Gerantol Geriatr 2004;39:125-132.

De Kroon JR, Lee JH, IJzerman MJ, et al. Therapeutic electrical stimulation to improve motor control andfunctional abilities of the upper extremity after stroke: a systematic review. Clin Rehabil 2002;16:350-360

Hara Y. Neurorehabilitation with new functional electrical stimulation for hemiparetic upper extremity in strokepatients. J Nippon Med Sch 2008;75:4-14

Kawakkel G, Kollen BJ Krebs HI. Effects of Robot-assisted on upper limb recovery after stroke: A systematicreview. Nerorrehabil Neural Repair 2008;22:111-121

Meilink A, Hemmen B, Sellen H, et al. Impact of EMG-triggered neuromuscular stimulation of the wrist and fingerextensors of the paretic hand after stroke . A systematic review of the literature. Clin Rehabil 2008;22:291-305.

Snoek GJ, IJzerman MJ, Groen FAC, et al. Use of the NESS Handmaster to restore hand function in tetraplegia:clinical experience in ten patients. Spinal Cord 2000;38:244-249.

Medical Technology AssessmentMTAC Criteria 12/03/07

L300 & H20010/06/08

H200

The technology must have the final approval from theappropriate government regulatory bodies.

Has FDA approval Has FDA approval

The scientific evidence must permit conclusions concerningthe effects of the technology on health outcomes.

Fails unanimous vote Fails unanimous vote

The technology must improve the net health outcome. Not considered since failedcriterion 2

Not considered since failedcriterion 2

The technology must be as beneficial as any establishedalternatives



The improvement must be attainable outside theinvestigational setting.



The use of technology must represent an efficient use oflimited health care resources



Creation Date MTAC Review Date


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12/21/2007 12/03/2007, 10/06/2008

MDCRPCMedical Director Clinical Review and Policy Committee

For questions or comments contact:Clinical Criteria Documentation Team
mailto:[email protected]?subject=Clinical%20Criteriamailto:[email protected]?subject=Clinical%20Criteriamailto:[email protected]?subject=Clinical%20Criteria