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Randomized Controlled Trial
. 2016 Jun;47(6):1562-70.
doi: 10.1161/STROKEAHA.115.012455. Epub 2016 May 10.

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

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Free PMC article
Randomized Controlled Trial

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

Philip M Bath et al. Stroke. .
Free PMC article

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.

Figures

Figure 1.
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.
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.

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