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).

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.