title: Pharyngeal Electrical Stimulation in Dysphagia Poststroke: A Prospective, Randomized Single-Blinded Interventional Study.
abstract: Background Pharyngeal electrical stimulation (PES) appears to promote cortical plasticity and swallowing recovery poststroke. Objective We aimed to assess clinical effectiveness with longer follow-up. Methods Dysphagic patients (n = 36; median = 71 years; 61% male) recruited from 3 trial centers within 6 weeks of stroke, received active or sham PES in a single-blinded randomized design via an intraluminal pharyngeal catheter (10 minutes, for 3days). The primary outcome measure was the Dysphagia Severity Rating (DSR) scale (<4, no-mild; ≥4, moderate-severe). Secondary outcomes included unsafe swallows on the Penetration-Aspiration Scale (PAS ≥ 3), times to hospital discharge, and nasogastric tube (NGT) removal. Data were analyzed using logistic regression. Odds/hazard ratios (ORs/HRs) >1 for DSR <4, hospital discharge, and NGT removal and OR <1 for PAS ≥3, indicated favorable outcomes for active PES. Results Two weeks post-active PES, 11/18 (61%) had DSR <4: OR (95% CI) = 2.5 (0.52, 14). Effects of active versus sham for secondary outcomes included the following: PAS ≥3 at 2 weeks, OR (95% CI) = 0.61 (0.27, 1.4); times to hospital discharge, 39 days versus 52 days, HR (95% CI) = 1.2 (0.55, 2.5); NGT removal 8 versus 14 days, HR (95% CI) = 2.0 (0.51, 7.9); and DSR <4 at 3 months, OR (95% CI) = 0.97 (0.13, 7.0). PES was well tolerated, without adverse effects or associations with serious complications (chest infections/death). Conclusions Although the direction of observed differences were consistent with PES accelerating swallowing recovery over the first 2 weeks postintervention, suboptimal recruitment prevents definitive conclusions. Our study design experience and outcome data are essential to inform a definitive, multicenter randomized trial.
authors.affiliation: University of Manchester, Salford, UK Salford Royal Foundation Trust, Salford, UK.
authors.forename: Dipesh H
authors.initials: DH
authors.lastname: Vasant
authors.affiliation: University of Manchester, Salford, UK Salford Royal Foundation Trust, Salford, UK.
authors.forename: Emilia
authors.initials: E
authors.lastname: Michou
authors.affiliation: University of Manchester, Salford, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: O'Leary
authors.affiliation: University of Manchester, Salford, UK Salford Royal Foundation Trust, Salford, UK.
authors.forename: Andy
authors.initials: A
authors.lastname: Vail
authors.affiliation: University of Manchester, Salford, UK Salford Royal Foundation Trust, Salford, UK.
authors.forename: Satish
authors.initials: S
authors.lastname: Mistry
authors.affiliation: University of Manchester, Salford, UK Salford Royal Foundation Trust, Salford, UK Shaheen.hamdy@manchester.ac.uk.
authors.forename: Shaheen
authors.initials: S
authors.lastname: Hamdy
mesh_terms: D000368:Aged; D003679:Deglutition / Q000502:physiology; D003680:Deglutition Disorders / Q000209:etiology* / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010614:Pharynx / Q000502:physiology*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016037:Single-Blind Method; D020521:Stroke / Q000150:complications*; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome
keywords: dysphagia; electrical stimulation; neurostimulation; pharynx; rehabilitation; stroke