NMES Clinical Update October 1, 2015 AAPM&R 2015

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NMES Clinical Update

October 1, 2015

Neuromuscular Electrical Stimulation and Dysphagia: A Clinical Update Martin B. Brodsky, Ph.D., Sc.M., CCC-SLP Assistant Professor Department of Physical Medicine and Rehabilitation October 1, 2015

Disclosures Grant no.: 1K23DC013569-01 Understanding and Improving Dysphagia after Mechanical Ventilation

Distribution of Research by Age

Roden & Altman (2013)

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

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 Martino et al., 2005

• 9x greater odds for death in patients who are aspirating thickened liquids. Schmidt et al., 1994

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

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

History of NMES and Dysphagia: FDA Study Submission Thermal (n = 58) Age in years, mean (range)

Sensory (n = 109)

Motor (n = 725)

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 Submission Swallow Function Score

Best Performance

0

Aspirates saliva

1

Handles only saliva

2

Pudding, Paste, Ice, Slush

3

Honey

4

Nectar

5

Thin Liquids

6

Water

Clinical Implication No solid or liquid is safe (aspiration highly likely or present) as above (candidate for PEG) Liquids not tolerated unless pudding consistency Able to tolerate increasing levels of liquids

Level of Swallow Deficit Profound Profound Significant Moderate Mild

No coffee, tea, juice or water Any viscosity is tolerated

Minimal 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…”

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

History of NMES and Dysphagia: FDA Study Submission And thus… 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 • Phagenyx

LATEST EVIDENCE IN STROKE: CLINICAL TRIALS RESULTS

Summary Evidence – 2007: Meta-Analysis of Clinical Trials • 7 studies: quantifiable trials, including randomized and quasiexperimental trials that included a measureable variable.

• 20% INCREASE in swallowing score following treatment. Carnaby-Mann & Crary, Arch Otolaryngol Head neck Surg, 2007

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

Functional Oral Intake Scale (FOIS): Crary, Mann, & Groher, 2005 LEVEL 1: NPO LEVEL 2: Tube dependent, minimal attempts of food or liquid LEVEL 3: Tube dependent with consistent oral intake of food or liquid LEVEL 4: Oral diet, single consistency LEVEL 5: Oral diet, multiple consistencies, requiring special preparation or compensations LEVEL 6: Oral diet, multiple consistencies, no special preparation, specific food limitations LEVEL 7: Total oral diet with no restrictions

Latest Evidence: Permsirivanich et al., J Med Assoc Thai, 2009 RCT: NMES alone (n = 12) vs. Traditional therapy alone (n = 26) Patients New stroke; persistent dysphagia >2 weeks Therapy 60 minutes 5 days/week 4 weeks

Latest Evidence: Lee et al., Ann Rehabil Med, 2014 RCT: NMES with traditional therapy (n = 31) vs. Traditional therapy alone (n = 26)

Patients New stroke Therapy 30 minutes 5 days/week 3 weeks

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

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

Vertical movement of the larynx

Therapy 20 minutes 3 days/week 4 weeks

Summary Evidence – 2015: Meta-Analysis of Clinical Trials 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 Chen et al., Clin Rehabil, 2015

Summary Evidence – 2015: Meta-Analysis of Clinical Trials Superiority of traditional therapy with NMES vs. Traditional therapy without NMES (n = 6 studies)

Confirmed SMD 1.27 (95% CI: 0.51, 2.02), p = 0.001 Chen et al., Clin Rehabil, 2015

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

Summary Evidence – 2015: Meta-Analysis of Clinical Trials Superiority of NMES alone vs. Traditional therapy alone (n = 3 studies)

Insufficient evidence SMD 1.27 (95% CI: 0.51, 2.02), p = 0.001 Chen et al., Clin Rehabil, 2015

SUMMARY AND FINAL 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

AAPM&R 2015 - Boston

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NMES Clinical Update

October 1, 2015

Final Thoughts Research for NMES 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

AAPM&R 2015 - Boston

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