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Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial
Philip M Bath1, Polly Scutt2, Jo Love2
1From the Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, United Kingdom (P.M.B., P.S.); Phagenesis, Ltd, Manchester Science Park, United Kingdom (J.L.); Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd), Hospital de Mataró, Universitat Autònoma de Mataró, Spain (P.C.); Stroke Service, Northwick Park Hospital, London, United Kingdom (D.C.); Department of Neurology, University Hospital Münster, Germany (R.D.); Department of Neurology, Glostrup Hospital and University of Copenhagen, Denmark (H.K.I.); Schoen Klinik Bad Aibling, Bad Aibling, Germany (C.L.); Stroke Service, Poole Hospital, Poole, United Kingdom (S.R.); Neurology Clinic, Bad Neustadt, Germany (H.S.); Acute Stroke Unit, University Hospitals of North Midlands, Stoke-on-Trent, United Kingdom (A.W.); Unité de la voix et de la deglutition, Service ORL CHU de Toulouse, Octogone Lordat Université Toulouse Mirail, France (V.W.); and Centre for Gastrointestinal Sciences, University of Manchester, United Kingdom (S.H.). philip.bath@nottingham.ac.uk.
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.
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