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
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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.
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Distribution of Research by Age
Roden & Altman (2013)
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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
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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
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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
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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)
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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
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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…”
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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
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LATEST EVIDENCE IN STROKE:CLINICAL TRIALS RESULTS
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• 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
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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SUMMARY ANDFINAL COMMENTS
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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
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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