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

TY - JOUR

T1 - Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke

T2 - A Randomized Controlled Trial

AU - Bath, Philip M W

AU - Scutt, Polly

AU - Love, Jo

AU - Clavé, Pere

AU - Cohen, David

AU - Dziewas, Rainer

AU - Iversen, Helle K

AU - Ledl, Christian

AU - Ragab, Suzanne

AU - Soda, Hassan

AU - Warusevitane, Anushka

AU - Woisard, Virginie

AU - Hamdy, Shaheen

AU - Swallowing Treatment Using Pharyngeal Electrical Stimulation (STEPS) Trial Investigators

N1 - © 2016 The Authors.

PY - 2016/6/1

Y1 - 2016/6/1

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Brain Ischemia

KW - Cerebral Hemorrhage

KW - Deglutition Disorders

KW - Double-Blind Method

KW - Electric Stimulation Therapy

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Outcome Assessment (Health Care)

KW - Pharynx

KW - Photofluorography

KW - Stroke

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

U2 - 10.1161/STROKEAHA.115.012455

DO - 10.1161/STROKEAHA.115.012455

M3 - Journal article

C2 - 27165955

SN - 0039-2499

VL - 47

SP - 1562-1570 + tillæg

JO - Stroke

JF - Stroke

IS - 6

ER -