A simple electrical probe placed in the throat could help stroke patients regain the ability to swallow safely. After a stroke, at least half of patients develop oropharyngeal dysphagia—difficulty swallowing that can lead to pneumonia, malnutrition, prolonged hospital stays, and death. No definitive treatments currently exist. Pharyngeal electrical stimulation (PES) works by sending electrical pulses through a catheter to the back of the throat, triggering sensory nerves that drive long-term rewiring of the brain’s swallowing control centres. Early trials suggest PES reduces swallowing difficulty, aspiration, and time in hospital, but the evidence is not yet definitive. This phase IV trial will randomise 800 severely dysphagic stroke patients across the UK, Austria, Denmark, and Germany to receive either six days of PES plus standard care, or standard care alone. The primary outcome is swallowing function at two weeks, measured by a validated severity scale. Secondary outcomes include pneumonia rates, feeding tube dependence, length of stay, quality of life, and cost-effectiveness. If PES proves effective and cost-saving, it could be rolled out rapidly across stroke units, changing clinical guidelines and reducing the long-term burden of dysphagia on patients, families, and health services.
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Research question Does pharyngeal electrical stimulation (PES) reduce dysphagia after stroke and is it safe and cost effective? Background Acute stroke (ischaemic, haemorrhagic) is common and complicated by oropharyngeal dysphagia in at least 50% of patients, many of whom remain dysphagic at one year. Dysphagia often requires enteral feeding and is complicated by aspiration/pneumonia, malnutrition, prolonged hospital stay, institutional care after hospital and death. Hence, it adds considerably to the physical, emotional and financial costs of stroke, delays discharge from hospital, and adds to health service usage and institutional burden. There are no definitive treatments for post-stroke dysphagia. Pharyngeal electrical stimulation (PES) increases afferent feedback from the pharynx to brain via bulbar cranial nerves and can drive long-term beneficial plasticity in cortical swallowing control. In phase II trials, PES was safe and well tolerated, and reduced clinical dysphagia (assessed using the validated dysphagia severity rating scale, DSRS), radiological aspiration, and length of stay in hospital in dysphagic patients after stroke. PES also facilitated decannulation in intubated stroke patients in phase II and III trials and improved dysphagia in a small trial in multiple sclerosis. The single-arm PHADER study showed that PES improved DSRS and instrumentally-assessed aspiration in patients with neurogenic dysphagia, including those with stroke. Whilst the evidence of beneficial effects of PES on neurogenic dysphagia is mounting, there remains uncertainty over its effectiveness in non-ventilated stroke patients. Aims/objectives: In comparison with usual care: - Primary: Does PES reduce dysphagia assessed using the DSRS? - Secondary: What subgroups predict DSRS response to PES? Does PES reduce hospital length of stay, pneumonia, antibiotic exposure and dependency, and increase quality of life and activities of daily living? Is PES cost effective? Methods We propose to do a large streamlined international (UK, Austria, Denmark, Germany) prospective randomised open-label blinded-endpoint phase IV trial of PES in 800 dysphagic patients with recent stroke. Patients with severe dysphagia within 4-31 days of stroke onset will be recruited. Following consent and randomisation, PES catheters will be inserted in active group participants and six days of treatment administered by a PES-trained research coordinator, nurse, speech therapist or medic. Control participants will receive standard-of-care with no PES catheter. The primary outcome is DSRS at 2 weeks post start of treatment. Secondary outcomes include hospital length of stay; dysphagia, dependency, disability, quality of life, pneumonia, need for feeding tube, death at 3 months; death at 1 year; and health economics. We will embed a Study Within A Trial (SWAT) aimed at maximising PES treatment current. Timelines for delivery The grant will last 39 months. 400 participants will receive PES in addition to standard-of-care and 400 standard-of-care alone, with groups followed to day 90, and death to one year. Impact and dissemination Although PES has a CE mark, the absence of definitive large trial data are limiting its use. If PES reduces dysphagia cost-effectively, it could be introduced rapidly across UK/European stroke units. Positive results will lead to multiple presentations/publications, considerable media coverage, and changes in clinical guidelines.
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