1. 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

2. Disclosures Grant no.: 1K23DC013569-01 Understanding and Improving Dysphagia after Mechanical Ventilation Royalties: MedBridge, Inc. No affiliation with the devices and/or companies mentioned during this presentation.

3. Distribution of Research by Age Roden & Altman (2013)

4. 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

5. 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

6. 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

7. 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 (%) Stroke36 (62)63 (58)347 (48) Neurodegenerative disease18 (31)25 (23)93 (13) Neuromuscular (e.g., MG, myopathy)0 ( 0) 10 ( 1) Post-polio syndrome0 ( 0) 2 (<1) Respiratory2 ( 3)14 (13)140 (19) Cancer2 ( 3)3 ( 3)56 (8) Iatrogenic0 ( 0)1 ( 1)16 ( 2) Other0 ( 0)3 ( 3)61 ( 8)

8. History of NMES and Dysphagia: FDA Study Submission Swallow Function Score Best Performance Clinical Implication Level of Swallow Deficit 0Aspirates saliva No solid or liquid is safe (aspiration highly likely or present) Profound 1Handles only saliva as above (candidate for PEG) Profound 2 Pudding, Paste, Ice, Slush Liquids not tolerated unless pudding consistency Significant 3Honey Able to tolerate increasing levels of liquids Moderate 4Nectar Mild 5Thin Liquids No coffee, tea, juice or water Minimal 6WaterAny viscosity is tolerated Normal

9. 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…”

10. 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

11. LATEST EVIDENCE IN STROKE: CLINICAL TRIALS RESULTS

12. 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 gain PAS, diet, patient perception

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

14. 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

15. 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

16. 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 Therapy 20 minutes 3 days/week 4 weeks Vertical movement of the larynx

17. 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

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

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

20. Latest Evidence: Suntrup et al., Intensive Care Med, 2015 RCT:Electrical Pharyngeal Stimulation (n = 20) vs. Sham control (n = 10) Patients Acute stroke, weaned from vent/trached, chronic dysphagia Therapy 10 minutes 3 days Results Successful 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

21. Latest Evidence: Suntrup et al., Intensive Care Med, 2015 RCT:Electrical Pharyngeal Stimulation (n = 20) vs. Sham control (n = 10) Patients Acute stroke, weaned from vent/trached, chronic dysphagia Therapy 10 minutes 3 days EPSControlp-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)

22. SUMMARY AND FINAL COMMENTS

23. 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

24. 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