Post-stroke dysphagia Signs and Symptoms Dysphagia
Conditions
Interventions
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 He
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
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
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
with 10% simple randomisation.
The intervention group will undergo PES administered on days 1-6 using a commercial catheter
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/11/2023: Dysphagia assessed using the Dysphagia Severity Rating Scale (DSRS), based on bedside clinical assessment/management conducted at days 14 (-1/+3). Outcome assessment will be assessed by DSRS/Functional Oral Intake Scale (FOIS)-trained research coordinators, nurses or SLTs who are not involved in treatment. _____ Previous primary outcome measure: Dysphagia assessed using the Dysphagia Severity Rating Scale (DSRS), based on bedside clinical assessment/management conducted at days 14±1. Outcome assessment will be assessed by DSRS/Functional Oral Intake Scale (FOIS)-trained research coordinators, nurses or SLTs who are not involved in treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/11/2023: Measured on Day 14 -1/+3 (day 13-17): 1. Dysphagia assessed using the Functional Oral Intake Scale (FOIS), Feeding Status Score (FSS), and Eating Assessment Tool (EAT-10) on bedside clinical assessment 2. Diagnosis of pneumonia or infection assessed using medical notes 3. Weight measured on bedside assessment 4. NG tube/PEG in situ 5. Quality of life assessed using EQ-VAS/EQ5D5L and Barthel Index (BI) on bedside clinical assessment 6. Level of consciousness using the Glasgow Coma Scale (GCS) 7. Cognition assessments (MoCA, TICS, MMSE, semantic verbal fluency, phonemic verbal fluency, IQCODE) 8. Penetration Aspiration Score (PAS) Measured on Day 90, Day 180 and Day 365 - all data collected via telephone assessment: 1. Dysphagia assessed using DSRS, FOIS, EAT-10 2. Feeding status assessed using FSS 3. Home-time measured in number of days participant has spent at home since stroke 4. Dependency assessed using modified Rankin Scale (mRS) 5. Disability assessed using Barthel Index (BI) 6. Quality of life assessed using EQ5D5L/EQVAS 7. Cognition assessed using Telephone interview for Cognitive Status (TICS) 8. Mood assessed using Zung depression scale 9. Disposition - where the participant has been discharged to - home, home with relatives, care home, residential home, nursing home, rehab unit Measured on Day 365: 1. All-cause mortality - data collected from GP to establish whether participant has died _____ Previous secondary outcome measures: Measured on Day 7: 1. Stimulation threshold assessed on bedside assessment 2. Tolerability of stimulation assessed on bedside assessment 3. Record of current used as recorded in medical notes 4. Number of catheters used as recorded in medical notes Measured on Day 14: 1. Dysphagia assessed using the Dysphagia Severity Rating Scale (DSRS), Functional Oral Intake Scale (FOIS), Eating Assessment Tool (EAT-10) on bedside clinical assessment 2. Feeding status assessed using FSS on | — |
Countries
Austria, Denmark, England, Germany, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactGemma Squires
Outcome results
None listed