Pharyngeal Electrical stimulation (PES) for Post Stroke dysphagia (PSD
Research type
Research Study
Full title
Pharyngeal Electrical stimulation for Acute Stroke dysphagia Trial (PhEAST)
IRAS ID
304658
Contact name
Philip Bath
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN98886991
Duration of Study in the UK
3 years, 5 months, 28 days
Research summary
Stroke (brain attack) is common and complicated by swallowing problems (dysphagia) in at least half of patients, many of whom still have abnormal swallowing a year later. Swallowing problems often lead to chest infections, poor nutrition, the need for a feeding tube inserted into the stomach, long hospital stays, disability and so nursing home care after hospital, and death. Patients dislike not being able to eat and drink normally, and they and their family dislike feeding tubes especially when used long-term. These issues reduce stroke survivor quality of life and add much to the physical, mental, emotional and financial cost of stroke. At present, there are no proven treatments for swallowing problems after stroke.
The control of swallowing uses nerves running between the back of the throat and the brain. In volunteers, stimulating these nerves using a tiny electric current has been shown to re-programme the swallowing centres in the brain. Pharyngeal electrical stimulation (PES) is given via a tube inserted through the nose to the back of the throat, and stimulation can barely be felt. In small and medium-sized trials, and summaries of their results, PES was safe, reduced swallowing problems (assessed using a scale called the ‘dysphagia severity rating scale’) and x-ray evidence of dangerous swallowing, and was acceptable to patients with swallowing problems after stroke. Good results have also been seen in studies in groups of patients with other brain problems and abnormal swallowing.
We would like to do a much larger and simpler trial of PES in 800 patients with recent stroke and needing a feeding tube because of abnormal swallowing. The aim is to see if PES is effective when used in the real-world. Recruitment will take place in 50 sites in 4 European countries (UK, Austria, Denmark, Germany). Following consent, patients will be allocated at random to either receive a treatment catheter and electrical stimulation, or to continue with their normal feeding tube. Treatment will be given for six days by a specially trained researcher, nurse or swallowing therapist. The main outcome will be improvement in swallowing using the dysphagia severity rating scale two weeks after starting treatment, and assessed without knowledge of treatment.
The cost of the treatment against the cost-savings from potentially improved swallowing and reduced stay in hospital will be assessed using health economic analyses. If PES improves swallowing and reduces complications such as pneumonia, and treatment is cost effective as compared to usual care, then it could be used widely after stroke in people with swallowing problems.REC name
East of England - Essex Research Ethics Committee
REC reference
21/EE/0252
Date of REC Opinion
16 Nov 2021
REC opinion
Favourable Opinion