Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke

Bath, Philip M.W.; Scutt, Polly; Love, Jo; Clav�, Pere; Cohen, David; Dziewas, Rainer; Iversen, Helle K.; Ledl, Christian; Ragab, Suzanne; Soda, Hassan; Warusevitane, Anushka; Woisard, Virginie; Hamdy, Shaheen

Abstract

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.
Clinical Trial Registration: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641.

Citation

Bath, P. M., Scutt, P., Love, J., Clavé, P., Cohen, D., Dziewas, R., …Hamdy, S. (in press). Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke. Stroke, 47(6), https://doi.org/10.1161/STROKEAHA.115.012455

• Journal Article Type: Article
• Acceptance Date: Apr 4, 2016
• Online Publication Date: May 10, 2016
• Deposit Date: Aug 4, 2016
• Publicly Available Date: Aug 4, 2016
• Journal: Stroke
• Print ISSN: 0039-2499
• Electronic ISSN: 0039-2499
• Publisher: American Heart Association
• Peer Reviewed: Peer Reviewed
• Volume: 47
• Issue: 6
• DOI: https://doi.org/10.1161/STROKEAHA.115.012455
• Keywords: Dysphagia : pharyngeal electrical stimulation ; randomized controlled trial ; stroke
• Public URL: https://nottingham-repository.worktribe.com/output/790474
• Publisher URL: http://stroke.ahajournals.org/content/47/6/1562.short