Pharyngeal electrical stimulation versus none for post stroke dysphagia: rationale, design and protocol for the parallel group superiority pharyngeal electrical stimulation for acute stroke dysphagia trial (PhEAST) (ISRCTN98886991)

Cerebrovascular Diseases Extra · Published 2026-07-21 · DOI 10.1159/000553643

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Authors (29)

Jacqueline K. Benfield, Lisa F. Everton, Lisa J. Woodhouse, Iris Mhlanga, Corinne Latulipe, Cameron J.C. Skinner, Amanda Buck, Gemma Squires, Cristina Roadevin, Roxanne Fiddy-Kent, Nazrana Munsif, Gwenllian Wilkinson, Kennedy M. Cadman, Tiffany Hamilton, Patrick Smith, Jason P. Appleton, Rainer Dziewas, Helle K. Iversen, Kailash Krishnan, Karl Matz, Satish Mistry, Craig J. Smith, Thorsten Steiner, Nikola Sprigg, Alan Montgomery, Marilyn James, Timothy J. England, Shaheen Hamdy, Philip M. Bath

Abstract

Introduction Acute ischaemic stroke and primary intracerebral haemorrhage are complicated by oropharyngeal dysphagia in more than 50% of patients. Currently, there are no definitive treatments for post-stroke dysphagia. Pharyngeal electrical stimulation (PES) can drive long-term beneficial changes in the cortical control of swallowing with functionally relevant reorganisation of the swallowing cortex correlating with reduced dysphagia. Methods The pharyngeal electrical stimulation for acute stroke dysphagia trial (PhEAST) is an international prospective randomised open-label blinded-endpoint parallel-group phase-4 superiority effectiveness trial. 638 patients with post-stroke dysphagia and dependency on nasogastric tube feeding are being recruited within 2 to 31 days of ictus. Participants are recruited from UK and Austria and randomised to six days of optimised PES (given for 10 minutes each day) versus no PES on top of standard care. The primary outcome is the dysphagia severity rating scale (DSRS), an assessment of swallowing impairment, measured locally on day 14 and centrally at day 90 by trained observers masked to treatment and analysed using repeated measures regression analysis. Secondary outcomes include: functional oral intake scale, feeding status scale, international dysphagia diet standardisation initiative scale, presence of a feeding tube, pneumonia, antibiotic use, health-related quality of life, dependency, disability, frailty, mood, cognition, global impact and health economics at days 14, 90, 180 and 365. Safety measures include death and serious adverse events. Discussion PhEAST has recruited more than 574 participants from 45 hospitals in the UK and Austria; recruitment will complete at end October 2026. The attached Supplement summarises the protocol and follows the EQUATOR SPIRIT guideline.

Abstract from DOAJ. Public domain (CC0 1.0).

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Publication details

Year
2026

Citation

Benfield, J., Everton, L., Woodhouse, L., et al. (2026). Pharyngeal electrical stimulation versus none for post stroke dysphagia: rationale, design and protocol for the parallel group superiority pharyngeal electrical stimulation for acute stroke dysphagia trial (PhEAST) (ISRCTN98886991). Cerebrovascular Diseases Extra. https://doi.org/10.1159/000553643

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