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

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.

Keywords: dysphagia; pharyngeal electrical stimulation; randomized controlled trial; stroke.

© 2016 The Authors.

Figures

Figure 1.

Flow of patients through the trial: consented, 195; screened with VFS, 181; randomized, 162; treatment attempted, 152; treated, 141; treated with VFS at 2 weeks, 126; all 3 treatments received with VFS at 2 weeks, 123; treated with VFS at 12 weeks, 95. AE indicates adverse event; CIP, clinical investigational plan; Rx, randomization; SLT, speech and language therapy; and VFS, videofluoroscopy.

Figure 2.

Effect of treatment on penetration aspiration score in prespecified subgroups determined at baseline, with analysis using adjusted multiple linear regression. CL indicates confidence limit; DSRS, dysphagia severity rating scale; LACS, lacunar circulation syndrome; MD, mean difference; NIHSS, National Institutes of Health Stroke Scale; PACS, partial anterior circulation syndrome; PAS, penetration aspiration score; PES, pharyngeal electric stimulation; and TACS, total anterior circulation syndrome.