Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial

Research output: Contribution to journalJournal articleResearchpeer-review


  • Philip M W Bath
  • Polly Scutt
  • Jo Love
  • Pere Clavé
  • David Cohen
  • Rainer Dziewas
  • Iversen, Helle Klingenberg
  • Christian Ledl
  • Suzanne Ragab
  • Hassan Soda
  • Anushka Warusevitane
  • Virginie Woisard
  • Shaheen Hamdy
  • Swallowing Treatment Using Pharyngeal Electrical Stimulation (STEPS) Trial Investigators

BACKGROUND AND PURPOSE: Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials.

METHODS: We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks.

RESULTS: In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred.

CONCLUSIONS: In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result.


Original languageEnglish
Issue number6
Pages (from-to)1562-1570 + tillæg
Number of pages9
Publication statusPublished - Jun 2016

    Research areas

  • Aged, Aged, 80 and over, Brain Ischemia, Cerebral Hemorrhage, Deglutition Disorders, Double-Blind Method, Electric Stimulation Therapy, Female, Humans, Male, Middle Aged, Outcome Assessment (Health Care), Pharynx, Photofluorography, Stroke, Journal Article, Multicenter Study, Randomized Controlled Trial

Number of downloads are based on statistics from Google Scholar and

No data available

ID: 179084684