neuromuscular electrical stimulation and dysphagia: a clinical update martin b. brodsky, ph.d.,...
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Neuromuscular Electrical Stimulation and Dysphagia: A Clinical Update
Martin B. Brodsky, Ph.D., Sc.M., CCC-SLPAssistant ProfessorDepartment of Physical Medicine and Rehabilitation
October 1, 2015
Disclosures
Grant no.: 1K23DC013569-01Understanding and ImprovingDysphagia after Mechanical Ventilation
Royalties: MedBridge, Inc.
No affiliation with the devices and/or companies mentioned during this presentation.
Distribution of Research by Age
Roden & Altman (2013)
Prevalence of Dysphagia:Adults in the U.S.
• 1 in 25 adults affected annually• Estimated 9.44 0.33 million adults report a swallowing
problem.• Overall, 23% saw a health care professional for their
swallowing problem, and 37% were given a diagnosis.• Commonly reported etiologies
– Stroke: 422,000 77,000– Other neurologic causes: 269,000 57,000– Head and neck cancer: 185,000 40,000
• Mean days affected by a swallowing problem was 139 7• 12 lost workdays in the past year vs. 3.4 lost workdays for
those without a swallowing problem Bhattacharyya, 2014
Dysphagia Implications
• 3x increased risk of pneumonia in patients with dysphagia
• 12x increased risk of pneumonia in patients with aspiration
• 9x greater odds for death in patients who are aspirating thickened liquids.
Martino et al., 2005
Schmidt et al., 1994
Martino et al., 2005
History of NMES and Dysphagia:FDA Study Submission
1993-1995– Randomized 58 patients (thermal stimulation) and
109 electrical stimulation (sensory stimulation)
June 1995– Motor stimulation: 1 patient who failed sensory
stimulation– Continued randomization with 30 more patients to
determine number of treatments necessary
1995 - 1998– Non-randomized 725: 100% motor stimulation
History of NMES and Dysphagia:FDA Study Submission
Thermal(n = 58)
Sensory(n = 109)
Motor(n = 725)
Age in years, mean (range) 79 (47-98) 75 (36-101) 72 (<1-100)
Males, n (%) 33 (57) 55 (50) 373 (51)
Condition, n (%)
Stroke 36 (62) 63 (58) 347 (48)
Neurodegenerative disease 18 (31) 25 (23) 93 (13)
Neuromuscular (e.g., MG, myopathy) 0 ( 0) 0 ( 0) 10 ( 1)
Post-polio syndrome 0 ( 0) 0 ( 0) 2 (<1)
Respiratory 2 ( 3) 14 (13) 140 (19)
Cancer 2 ( 3) 3 ( 3) 56 (8)
Iatrogenic 0 ( 0) 1 ( 1) 16 ( 2)
Other 0 ( 0) 3 ( 3) 61 ( 8)
History of NMES and Dysphagia:FDA Study SubmissionSwallow Function
ScoreBest
PerformanceClinical
Implication
Level ofSwallow Deficit
0 Aspirates salivaNo solid or liquid is safe (aspiration highly likely or present)
Profound
1 Handles only salivaas above (candidate for PEG) Profound
2 Pudding, Paste, Ice, Slush
Liquids not tolerated unless pudding consistency
Significant
3 Honey Able to tolerate increasing levels of liquids
Moderate
4 Nectar Mild
5 Thin LiquidsNo coffee, tea, juice or water Minimal
6 Water Any viscosity is tolerated Normal
History of NMES and Dysphagia:FDA Study Submission
Results• BOTH sensory stimulation and motor stimulation were
more effective than thermal stimulation
• Sensory and Motor were “indistinguishable” after 2 treatments…and only to Level 4 (nectar)
• Sensory: 6 treatments; Motor: 5 treatments for similar improvements
• “For patients with severe dysphagia, electrical stimulation had a success rate of 97.5% of restoring swallowing patients past the point of requiring a PEG…”
History of NMES and Dysphagia:FDA Study Submission
And thus…2002: FDA 510(k) approval to market VitalStim (Chattanooga Group, Hixon TN) for external NMES in the laryngeal neck region.
Other devices on the market• eSWALLOW• Spectramed• Ampcare ESP• Phagenyx
LATEST EVIDENCE IN STROKE:CLINICAL TRIALS RESULTS
• 7 studies: quantifiable trials, including randomized and quasi-experimental trials that included a measureable variable.
• 20% INCREASE in swallowing score following treatment.
Summary Evidence – 2007:Meta-Analysis of Clinical Trials
Carnaby-Mann & Crary, Arch Otolaryngol Head neck Surg, 2007
Laryngeal elevation, weight gainPAS, diet, patient perception
Functional Oral Intake Scale(FOIS): Crary, Mann, & Groher, 2005
LEVEL 7: Total oral diet with no restrictionsLEVEL 6: Oral diet, multiple consistencies, no special
preparation, specific food limitationsLEVEL 5: Oral diet, multiple consistencies, requiring
special preparation or compensationsLEVEL 4: Oral diet, single consistencyLEVEL 3: Tube dependent with consistent oral intake
of food or liquidLEVEL 2: Tube dependent, minimal attempts of food
or liquidLEVEL 1: NPO
Latest Evidence:Permsirivanich et al., J Med Assoc Thai, 2009
RCT: NMES alone (n = 12) vs. Traditional therapy alone (n = 26)
PatientsNew stroke; persistent dysphagia >2 weeks
Therapy60 minutes5 days/week4 weeks
Latest Evidence:Lee et al., Ann Rehabil Med, 2014
RCT: NMES with traditional therapy (n = 31) vs. Traditional therapy alone (n = 26)
PatientsNew stroke
Therapy30 minutes5 days/week3 weeks
Latest Evidence:Park et al., Dysphagia, 2012
RCT: Motor NMES + effortful swallow (n = 9) vs. Sensory NMES + effortful swallow (n = 9)
Patients>1 month post-stroke; dysphagia
Therapy20 minutes3 days/week4 weeks
Vertical movement of the larynx
8 studies: Randomized and quasi-randomized controlled trials
Goals of the systematic review with meta-analysis
To determine:
1. Superiority of traditional therapy with NMES vs. Traditional therapy without NMES
2. Superiority of NMES alone vs. Traditional therapy alone
Summary Evidence – 2015:Meta-Analysis of Clinical Trials
Chen et al., Clin Rehabil, 2015
Superiority of traditional therapy with NMES vs. Traditional therapy without NMES (n = 6 studies)
ConfirmedSMD 1.27 (95% CI: 0.51, 2.02), p = 0.001
Summary Evidence – 2015:Meta-Analysis of Clinical Trials
Chen et al., Clin Rehabil, 2015
Superiority of NMES alone vs. Traditional therapy alone (n = 3 studies)
Insufficient evidenceSMD 1.27 (95% CI: 0.51, 2.02), p = 0.001
Summary Evidence – 2015:Meta-Analysis of Clinical Trials
Chen et al., Clin Rehabil, 2015
Latest Evidence:Suntrup et al., Intensive Care Med, 2015
RCT: Electrical Pharyngeal Stimulation (n = 20) vs. Sham control (n = 10)
PatientsAcute stroke, weaned from vent/trached, chronic dysphagia
Therapy10 minutes3 days
ResultsSuccessful decannulation in 72 hours• EPS: 15/20 (75%)• Sham: 2/10 (20%)
Remaining 8 in control received EPS• 1/8 (13%) t/f’d to rehab/no tx• 5/7 (71%) decannulated
Latest Evidence:Suntrup et al., Intensive Care Med, 2015
RCT: Electrical Pharyngeal Stimulation (n = 20) vs. Sham control (n = 10)
PatientsAcute stroke, weaned from vent/trached, chronic dysphagia
Therapy10 minutes3 days
EPS Control p-value
Time in hospital (days)
LOS, mean (SD) 43 (17) 42 (21) 0.95
ICU LOS, mean (SD) 38 (15) 39 (20) 0.92
Time (tx–to–d/c), mean (SD) 16 (12) 10 ( 6) 0.55
FOIS at hospital discharge
Tube dependent (1-3), n (%) 8 (40) 6 (60)0.30
Total oral intake (4-7), n (5) 12 (60) 4 (40)
SUMMARY ANDFINAL COMMENTS
Summary
Reviews and RCTs…• Presented limited numbers of studies
• Studies had low numbers of subjects
• Most studies have methodological shortcomings– Masking assessors only– Lack of details for interventions used
• DO lend support for use of NMES with traditional therapy
Final Thoughts
Research for NMES/EPS and dysphagia treatment is in its infancy
First RCT was 6 years after FDA approval of VitalStim
Future studies MUST be…• Methodologically well-controlled• Adequately detailed for replication• Larger to improved adequacy of statistical power
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