Click here to read a summary of the research on NMES and dysphagia treatment

Safety
The use of NMES in the treatment of dysphagia has been consistently demonstrated to be safe.

In tracking for the occurrence of adverse events during clinical studies, none were reported across all patient ages and diagnoses. During the initial FDA clearance study (1) and in all known studies since, there have been:

  • no reports of laryngospasm
  • no reports of bradycardia 
  • no reports of electromagnetic interference with cardiac pacemakers
  • no changes in pulse oxymetry readings, heart rate, or blood pressure

Efficacy
There are currently numerous positive studies and a meta-analysis in print that corroborate the positive findings reported in the field. The findings include the following:

  • The use of electrical stimulation seems to contribute significantly to the improvement in swallow function (2)
  • NMES in conjunction with swallowing exercise seems to be more effective than traditional treatment techniques alone (3)
  • Use of NMES tends to decrease inpatient length of stay as a result of improved swallow function (3)
  • Mild (limited oral intake) to moderate (PEG fed with minimal oral intake) dysphagia patients benefit the most with over 80% discontinuing PEG (4)

User and patient satisfaction
Besides the growing empirical evidence base, the adoption of theVitalStim® Therapy System is increasing as a result of widespread reports of good patient outcomes and good patient satisfaction. Crary and colleagues confirmed these outcomes in an independent user survey of 2000 Speech Pathologists (5). 

 

References

  1. Freed ML. Clinical trial data in support of VitalStim 510(k) clearance application with FDA. 2001.
  2. Carnaby-Mann GD, and Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg 133: 564-571, 2007.
  3. Blumenfeld L, Hahn Y, Lepage A, Leonard R, and Belafsky PC Transcutaneous electrical stimulation versus traditional dysphagia therapy: nonconcurrent cohort study. Otolaryngol Head Neck Surg 135: 754-757, 2006.
  4. Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, and Dowdy E. Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol 116: 36-44, 2007.
  5. Crary MA, Carnaby-Mann GD, and Faunce A. Electrical stimulation therapy for dysphagia: descriptive results of two surveys. Dysphagia 22: 165-173, 2007.