Pharyngeal Electrical stimulation for Acute Stroke dysphagia Trial (PhEAST)
Post-stroke dysphagia
Current intervention as of 14/11/2023: Randomised will be 1:1 with stratification on country and minimisation on age, sex, dysphagia severity rating scale (DSRS), impairment (National Institutes of Health stroke scale [NIHSS]), stroke type (ischaemic/haemorrhagic), circulation (anterior/posterior), time to randomisation; with 10% simple randomisation. The intervention group will undergo PES administered for 6, ideally consecutive, days using a commercial catheter with an integral feeding tube. PES involves six daily 10 minute treatments at 5 Hz; threshold and tolerability currents will be assessed and the treatment current set at threshold + 0.75 x (tolerability - threshold) with the current generated by a base station. Dosing levels will be monitored, and sites informed if the stimulation current is too low, i.e. <20 mA; sites will be re-trained on the importance of delivering adequate current, if necessary. The catheter will be replaced once only if pulled out before three treatments have been administered. Treatment will be administered by PES-trained research coordinators, nurses or speech and language therapists (SLTs) who are not involved in outcome data collection. The control group will receive no PES catheter/stimulation on top of best guideline-based dysphagia management. A standard NGT will be used for feeding as necessary. _____ Previous intervention: Randomised will be 1:1 with stratification on country and minimisation on age, sex, dysphagia severity rating scale (DSRS), impairment (National Institutes of Health stroke scale [NIHSS]), stroke type (ischaemic/haemorrhagic), circulation (anterior/posterior), time to randomisation; with 10% simple randomisation. The intervention group will undergo PES administered on days 1-6 using a commercial catheter with an integral feeding tube. PES involves six daily 10 minute treatments at 5 Hz; threshold and tolerability currents will be assessed and the treatment current set at threshold + 0.75 x (tolerabili
Current inclusion criteria as of 14/11/2023: 1. Hospitalised adults (age ≥18 years) 2. Recent (4-31 days) ischaemic or haemorrhagic anterior or posterior circulation stroke (as diagnosed clinico-radiologically) at a comprehensive or primary care stroke centre 3. Clinical dysphagia defined as a functional oral intake scale score of 1 (nothing by mouth, feeding by nasogastric tube [NGT]/percutaneous endoscopic gastrostomy [PEG] tube), 2 (tube dependent with minimal attempts of food or liquids) or 3 (tube dependent with consistent oral intake of food or liquids) 4. NIHSS item 1a score of 0, 1 or 2 (where the patient requires repeated stimulation to arouse) _____ Previous inclusion criteria: 1. Hospitalised adults (age ≥18 years) 2. Recent (4-31 days) ischaemic or haemorrhagic anterior or posterior circulation stroke (as diagnosed clinico-radiologically) at a comprehensive or primary care stroke centre 3. Clinical dysphagia defined as a functional oral intake scale score of 1 (nothing by mouth, feeding by nasogastric tube [NGT]/percutaneous endoscopic gastrostomy [PEG] tube) or 2 (tube dependent with minimal attempts of food or liquids)
Current exclusion criteria as of 14/11/2023: 1. Non-stroke dysphagia, e.g. due to traumatic brain haemorrhage, subarachnoid haemorrhage, brain tumour, Parkinson’s disease, multiple sclerosis, severe dementia, head or neck cancer 2. Pre-stroke dysphagia or dependency (modified Rankin scale, mRS 4/5) 3. NIHSS item 1a score of 2 (where the patient only responds to pain) or NIHSS item 1a score of 3 4. Ongoing or anticipated ventilation/intubation/tracheostomy 5. Ongoing treatment of dysphagia with other forms of electrical / magnetic stimulation e.g. NMES, TCDS, rTMS 6. Malignant middle cerebral artery syndrome (although this typically presents before 4 days) 7. Pacemaker, cochlear implant or implantable cardioverter-defibrillator 8. Need for >35% of oxygen 9. Patient expected to be repatriated to a separate organisation 10. Patient expected to be rehabilitated at a separate organisation 11. Patient not likely to be in the treating hospital for at least 14 days 12. Two or more NGT tubes pulled out unless nasal bridle in place 13. Investigator feels patient will not tolerate PES catheter 14. Expected to be discharged or transferred to a site not running the trial during the PES treatment period 15. Pregnancy if known at time of enrolment 16. Participating in another randomised controlled treatment trial for post-stroke dysphagia 17. Palliative care _____ Previous exclusion criteria: 1. Non-stroke dysphagia, e.g., due to traumatic brain haemorrhage, subarachnoid haemorrhage, brain tumour, Parkinson’s disease, multiple sclerosis, severe dementia, head or neck cancer 2. Pre-stroke dysphagia or dependency (modified Rankin scale [mRS] 4/5) 3. Ongoing or anticipated ventilation/intubation/tracheostomy or use of electrical or magnetic stimulation 4. Malignant middle cerebral artery syndrome 5. Pregnant 6. Pacemaker 7. Need for >2 litres of oxygen 8. Two or more NGT pulled out unless nasal bridle in place 9. Investigator feels the patient will not tolerate PES catheter