title: Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641.
authors.affiliation: From 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.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Bath
authors.affiliation: From 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.).
authors.forename: Polly
authors.initials: P
authors.lastname: Scutt
authors.affiliation: From 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.).
authors.forename: Jo
authors.initials: J
authors.lastname: Love
authors.affiliation: From 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.).
authors.forename: Pere
authors.initials: P
authors.lastname: Clavé
authors.affiliation: From 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.).
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.affiliation: From 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.).
authors.forename: Rainer
authors.initials: R
authors.lastname: Dziewas
authors.affiliation: From 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.).
authors.forename: Helle K
authors.initials: HK
authors.lastname: Iversen
authors.affiliation: From 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.).
authors.forename: Christian
authors.initials: C
authors.lastname: Ledl
authors.affiliation: From 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.).
authors.forename: Suzanne
authors.initials: S
authors.lastname: Ragab
authors.affiliation: From 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.).
authors.forename: Hassan
authors.initials: H
authors.lastname: Soda
authors.affiliation: From 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.).
authors.forename: Anushka
authors.initials: A
authors.lastname: Warusevitane
authors.affiliation: From 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.).
authors.forename: Virginie
authors.initials: V
authors.lastname: Woisard
authors.affiliation: From 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.).
authors.forename: Shaheen
authors.initials: S
authors.lastname: Hamdy
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000150:complications; D002543:Cerebral Hemorrhage / Q000150:complications; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy*; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010614:Pharynx / Q000503:physiopathology*; D010779:Photofluorography; D020521:Stroke / Q000150:complications*
keywords: dysphagia; pharyngeal electrical stimulation; randomized controlled trial; stroke