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).
Overview
and 9 other authors
Satish Mistry9, Craig J. Smith10,11, Thorsten Steiner12,13, Nikola Sprigg1,4, Alan A. Montgomery3, Marilyn James3, Timothy J. England1,5, Shaheen Hamdy14, Philip M. Bath1,414 affiliations
- Stroke Trials Unit, Mental Health and Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK
- Acute Speech and Language Therapy Department, Nottingham University Hospitals NHS Trust, Nottingham, UK
- Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK
- Stroke, Department of Medicine, Nottingham University Hospitals NHS Trust, Nottingham, UK
- Stroke, University Hospitals of Derby and Burton, Derby, UK
- Department of Neurology and Neurorehabilitation, Klinikum Osnabrueck—Academic Teaching Hospital of the University Muenster, Osnabrueck, Germany
- Department of Neurology, University Hospital Rigshospitalet, Copenhagen, Denmark
- Centre for Clinical Neurosciences and Prevention, University of Continuing Education Krems, Krems, Austria
- Phagenesis Ltd, Manchester, UK
- Division of Cardiovascular Sciences, University of Manchester, Manchester, UK
- Manchester Centre for Clinical Neurosciences, Geoffrey Jefferson Brain Research Centre, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK
- Department of Neurology, Varisano Klinikum Frankfurt Höchst, Frankfurt, Germany
- Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany
- Centre for Gastrointestinal Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
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 (PSD). 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. A total of 638 patients with PSD and dependency on nasogastric tube feeding are being recruited within 2–31 days of ictus. Participants are recruited from the UK and Austria and randomised to 6 days of optimised PES (given for 10 min each day) vs. no PES on top of standard care. The primary outcome is the dysphagia severity rating scale, 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.
Conclusion: PhEAST has recruited more than 574 participants from 45 hospitals in the UK and Austria; recruitment will be complete at the end of October 2026. The attached Supplement summarises the protocol and follows the EQUATOR SPIRIT guideline.
Reproduced under the paper's license (CC BY-NC), from the paper cited above.
Code
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Data
Datasets cited
- figshare:33033464, at figshare; found in DataCite
Data Availability Statement
Once completed, individual patient data will be shared with the virtual international stroke trials archive. See the online supplement for further details.
Reproduced under the paper's license (CC BY-NC), from the paper cited above.
Versions
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Version 2, 28 September 2026
- Authors: added Iris Isheanesu Mhlanga (0000-0003-3475-1630); Cameron J.C. Skinner (0009-0005-2235-6950); Amanda Buck (0009-0005-9525-2319); Gwenllian Wilkinson (0000-0001-5825-6891); Kennedy M. Cadman (0009-0002-8769-7447); Jason P. Appleton (0000-0002-2604-4410); Rainer Dziewas (0000-0003-1592-8461); Kailash Krishnan (0000-0002-6486-3783); Karl Matz (0000-0002-2851-9897); Satish Mistry (0000-0003-4529-7197); Craig J. Smith (0000-0002-9078-9919); Thorsten Steiner (0000-0002-5080-8222); Nikola Sprigg (0000-0002-5871-8168); Alan A. Montgomery (0000-0003-0450-1606); Marilyn James (0000-0003-0408-7898); Timothy J. England (0000-0001-5330-8584); Philip M. Bath (0000-0003-2734-5132); removed Iris Isheanesu Mhlanga; Cameron J.C. Skinner; Amanda Buck; Gwenllian Wilkinson; Kennedy M. Cadman; Jason P. Appleton; Rainer Dziewas; Kailash Krishnan; Karl Matz; Satish Mistry; Craig J. Smith; Thorsten Steiner; Nikola Sprigg; Alan A. Montgomery; Marilyn James; Timothy J. England; Philip M. Bath
Version 1, 27 September 2026: the first record
Recorded: type, language, journal, volume, issue, pages, dates, 29 authors, 5 keywords, 18 MeSH terms, 1 funder, 19 references.
Cite
This paper
Benfield, J. K., Everton, L. F., Woodhouse, L. J., Mhlanga, I. I., Latulipe, C., Skinner, C. J., Buck, A., Squires, G., Roadevin, C., Fiddy-Kent, R., Munsif, N., Wilkinson, G., Cadman, K. M., Hamilton, T., Smith, P., Appleton, J. P., Dziewas, R., Iversen, H. K., Krishnan, K., . . . Bath, P. M. (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, 16(1), 248-254. https://
BibTeX
@article{benfield2026pha
author = {Benfield, Jacqueline K. and Everton, Lisa F. and Woodhouse, Lisa J. and Mhlanga, Iris Isheanesu and Latulipe, Corinne and Skinner, Cameron J.C. and Buck, Amanda and Squires, Gemma and Roadevin, Cristina and Fiddy-Kent, Roxanne and Munsif, Nazrana and Wilkinson, Gwenllian and Cadman, Kennedy M. and Hamilton, Tiffany and Smith, Patrick and Appleton, Jason P. and Dziewas, Rainer and Iversen, Helle K. and Krishnan, Kailash and Matz, Karl and Mistry, Satish and Smith, Craig J. and Steiner, Thorsten and Sprigg, Nikola and Montgomery, Alan A. and James, Marilyn and England, Timothy J. and Hamdy, Shaheen and Bath, Philip M.},
title = {{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)}},
journal = {Cerebrovascular diseases extra},
year = {2026},
month = jul,
volume = {16},
number = {1},
pages = {248--254},
publisher = {Karger Publishers},
issn = {1664-5456},
doi = {10.1159/
url = {https://
pmid = {42479663},
pmcid = {PMC13498320}
}
RIS
TY - JOUR
AU - Benfield, Jacqueline K.
AU - Everton, Lisa F.
AU - Woodhouse, Lisa J.
AU - Mhlanga, Iris Isheanesu
AU - Latulipe, Corinne
AU - Skinner, Cameron J.C.
AU - Buck, Amanda
AU - Squires, Gemma
AU - Roadevin, Cristina
AU - Fiddy-Kent, Roxanne
AU - Munsif, Nazrana
AU - Wilkinson, Gwenllian
AU - Cadman, Kennedy M.
AU - Hamilton, Tiffany
AU - Smith, Patrick
AU - Appleton, Jason P.
AU - Dziewas, Rainer
AU - Iversen, Helle K.
AU - Krishnan, Kailash
AU - Matz, Karl
AU - Mistry, Satish
AU - Smith, Craig J.
AU - Steiner, Thorsten
AU - Sprigg, Nikola
AU - Montgomery, Alan A.
AU - James, Marilyn
AU - England, Timothy J.
AU - Hamdy, Shaheen
AU - Bath, Philip M.
TI - 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)
T2 - Cerebrovascular diseases extra
J2 - Cerebrovasc Dis Extra
PY - 2026
DA - 2026/
VL - 16
IS - 1
SP - 248
EP - 254
SN - 1664-5456
PB - Karger Publishers
DO - 10.1159/
UR - https://
LA - en
ER -
CSL-JSON
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