Pharyngeal electrical stimulation to treat dysphagia in acute stroke: learnings from cases in the PhEED clinical trial

Authors

  • Richard L. Harvey Brain Innovation Center, Shirley Ryan Ability Lab, Chicago, Illinois USA
  • Richard Smith Stroke Neurorehabilitation, St Anthony Hospital, CommonSpirit, Lakewood, Colorado USA
  • Rajaram Bathula Stroke, London Northwest University Healthcare NHS Trust, Northwick Park Hospital, Harrow UK
  • Lisa Everton Adult Speech & Language Therapy Department, Nottingham University Hospitals NHS Trust, Nottingham UK
  • Nicole Rup Carolinas Rehabilitation NorthEast, Atrium Health, Concord, North Carolina USA
  • Jeff Saver Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, California USA
  • Bonnie Martin-Harris School of Communication, Feinberg School of Medicine, Northwestern University, Evanston, Illinois USA
  • Rainer Dziewas Department of Neurology and Neurorehabilitation, Klinikum Osnabrueck, Osnabrueck, Germany
  • Satish Mistry Phagenesis Ltd, Manchester, UK
  • Shaheen Hamdy Phagenesis Ltd, Manchester, UK; Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Manchester UK
  • Philip Bath Stroke, Nottingham University Hospitals NHS Trust, Nottingham UK; Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham UK

DOI:

https://doi.org/10.2340/jrm.v57.43538

Keywords:

Stroke, Dysphagia, deglutition disorders, electrical stimulation therapy

Abstract

Objective: To assess the efficacy of pharyngeal electrical stimulation in improving dysphagia post-stroke.

Design: A randomized, sham-controlled, blinded multicentre clinical trial.

Subjects/Patients: Seventeen patients with acute ischaemic or haemorrhagic stroke experiencing dysphagia, indicated by a penetration aspiration scale score of 4–8 on videofluoroscopy.

Methods: Sites enrolled 3 open-label roll-in participants and then randomized subsequent participants to either stimulation or sham treatment. Study interventions were delivered for 10 min daily over 3 consecutive days. Prior to data lock the primary outcome was modified to the change in dysphagia severity rating scale from pre-treatment to end of follow-up period. Secondary outcomes included penetration-aspiration scale score assessed via videofluoroscopy 48 h after final treatment and functional oral intake scale, measured at 7, 14, and 83 days post-randomization.

Results: The trial was halted early due to low recruitment, with 15 participants receiving active stimulation and 2 receiving sham treatment. Active stimulation significantly reduced dysphagia severity at day 83 (difference: –4, p = 0.027). Improvements were observed in diet and supervision subscales, and functional oral intake scores. Of those treated, 67% were discharged home, with no serious adverse events attributable to the intervention noted in either group.

Conclusion: Pharyngeal electrical stimulation was safe and associated with reduced dysphagia severity in stroke patients, warranting further validation in larger studies.

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Published

2025-09-05

How to Cite

Harvey, R. L., Smith, R., Bathula, R., Everton, L., Rup, N., Saver, J., … Bath, P. (2025). Pharyngeal electrical stimulation to treat dysphagia in acute stroke: learnings from cases in the PhEED clinical trial. Journal of Rehabilitation Medicine, 57, jrm43538. https://doi.org/10.2340/jrm.v57.43538

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Vol. 57 (2025)

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Original Report

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Copyright (c) 2025 Richard L. Harvey, Richard Smith, Rajaram Bathula, Lisa Everton, Nicole Rup, Jeff Saver, Bonnie Martin-Harris, Rainer Dziewas, Satish Mistry, Shaheen Hamdy, Philip Bath

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