Electrical stimulation of the throat for swallowing difficulties after stroke
| ISRCTN | ISRCTN98886991 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98886991 |
| IRAS number | 304658 |
| Secondary identifying numbers | IRAS 304658, NIHR132016, CPMS 50913 |
- Submission date
- 30/09/2021
- Registration date
- 05/10/2021
- Last edited
- 14/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Acute stroke is common and complicated by dysphagia (swallowing problems) in over 50% of patients, many of whom remain dysphagic a year later. Post-stroke dysphagia (PSD) is an independent predictor of poor outcome and can lead to aspiration of material into the lungs, pneumonia, malnutrition and death. Patients often need feeding through a tube, have a prolonged hospital stay, and end up in long-term institutional care. PSD negatively impacts quality of life and its care is expensive and may be a tipping point for admission to residential care. Pharyngeal electrical stimulation (PES) is electrical stimulation of certain areas of the throat that stimulates the areas of the brain involved in swallowing. This study aims to find out whether PES is safe and effective at improving post-stroke dysphagia.
Who can participate?
Hospitalised adults (aged 18 years and over) with recent stroke (within 4-31 days) and dysphagia
What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention group receives PES on days 1-6 using a commercial catheter (tube) with an integral feeding tube. PES involves six daily 10 minute treatments. The control group will receive no PES catheter/stimulation on top of best guideline-based dysphagia management. A standard tube will be used for feeding as necessary.
What are the possible benefits and risks of participating?
The PES system is a non-significant risk device and its safety is shown by evidence from multiple studies over a period of 15 years. There are no characteristic device or treatment specific effects that are considered to be serious adverse events.
Where is the study run from?
University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
July 2021 to July 2025
Who is funding the study?
University of Nottingham (UK)
Who is the main contact?
Philip Bath
Philip.bath@nottingham.ac.uk
Contact information
Scientific
Stroke Trials Unit
Mental Health & Clinical Neurosciences
University of Nottingham
D Floor, South Block, Room 2117
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 82 31768 |
|---|---|
| philip.bath@nottingham.ac.uk |
Public
Stroke Trials Unit
Mental Health & Clinical Neurosciences
University of Nottingham
D Floor, South Block, Room 2151
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)82 31255 |
|---|---|
| Gemma.Squires1@nottingham.ac.uk |
Study information
| Study design | International prospective randomized open-label blinded-endpoint (PROBE) parallel-group superiority Phase IV effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Pharyngeal Electrical stimulation for Acute Stroke dysphagia Trial (PhEAST) |
| Study acronym | PhEAST |
| Study hypothesis | To assess whether pharyngeal electrical stimulation (PES) is safe and effective at improving post-stroke dysphagia. |
| Ethics approval(s) | Approved 07/01/2022, East of England - Essex Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048227; essex.rec@hra.nhs.uk), ref: 21/EE/0252 |
| Condition | Post-stroke dysphagia |
| Intervention | 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 (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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Phagenyx® (Phagenesis Ltd, Manchester, UK) |
| Primary outcome measure | 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 outcome measures | 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 bedside clinical assessment 3. Diagnosis of pneumonia or infection assessed using medical notes 4. Weight measured on bedside assessment 5. NG tube/PEG in situ/feeding status recorded using FSS from medical notes 6. Quality of life assessed using EQ-VAS/EQ5D5L on bedside clinical assessment 7. Discharge/death, data collected from the medical notes on discharge 8. Length of stay measured in number of days from admission to discharge 9. Swallowing therapy contact time measured in minutes spent with participant 10. Time to removal of NG tube/PEG - length of time participant has NG/PEG in situ measured in days 11. ICU admission measured in number of days spent in ITU 12. Discharged with PEG - answer yes/no if participant discharged with PEG 13. Disposition - where the participant has been discharged to - home, home with relatives, care home, residential home, nursing home, rehab unit Measured on Day 90 - 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 |
| Overall study start date | 29/07/2021 |
| Overall study end date | 30/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 30/05/2022 |
| Recruitment end date | 30/11/2024 |
Locations
Countries of recruitment
- Austria
- Denmark
- England
- Germany
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Aberdeen
AB25 2ZN
United Kingdom
Bath
BA1 3NG
United Kingdom
Belfast
BT12 6BA
United Kingdom
Derby
DE22 3NE
United Kingdom
King's Lynn
PE30 4ET
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
London
SW17 0QT
United Kingdom
Luton
LU4 0DZ
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Taunton
TA1 5DA
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Mansfield
NG17 4JL
United Kingdom
Llandough
Penarth
CF64 2XX
United Kingdom
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Leeds
LS1 3EX
United Kingdom
Bury St. Edmunds
IP33 2QZ
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
Room East Atrium Jubilee Conference centre
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
England
United Kingdom
| Phone | +44 (0)115 8467906 |
|---|---|
| bb-sponsor@exmail.nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Ongoing trial presentations at the UK Stroke Forum, European Stroke Organisation Conference, International Stroke Conference and World Stroke Conference 2. Protocol, statistical analysis plan and baseline characteristic publications in open-access journals (e.g. International Journal of Stroke, European Stroke Journal) 3. Primary results: oral presentation at a large international stroke conference times as per one of the above conferences. Open access publication in high impact journal to ensure maximum impact and rapid dissemination 4. Publication in HTA monograph 5. Secondary/tertiary/post hoc analyses: in appropriate journals (e.g. Stroke) 6. Subsequent presentations to inform UK, European and international guidelines 7. Provide evidence for NICE single technology appraisal (STA) assessment and guidance 8. Data sharing with the VISTA Stroke archive |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from PhEAST@nottingham.ac.uk addressed to the Trial Manager. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 02/12/2021 | 15/03/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
14/11/2023: The following changes have been made:
1. The intervention has been changed.
2. The primary outcome measure has been changed.
3. The secondary outcome measures have been changed.
4. The participant inclusion criteria have been changed.
5. The participant exclusion criteria have been changed.
6. Southmead Hospital, Blackpool Teaching Hospital, Glangwili General Hospital, Ashford & St Peters Hospital, Countess of Chester Hospital, Chesterfield Royal Hospital, Worthing Hospital, Doncaster Royal Infirmary, Glasgow Queen Elizabeth Hospital, Withybush General Hospital, Prince Philip Hospital, King's College Hospital, Princess Royal University Hospital, Royal Victoria Infirmary, Peterborough City Hospital, Poole Hospital, Royal Preston Hospital, Royal Hallamshire Hospital, Pinderfields Hospital, Watford General Hospital, Southend University Hospital, Wrexham Maelor Hospital, Yeovil Hospital, Chefarzi der Neurologischen Klinik des EvKB, Darmstadt Klinikum, University Hospital Munster, Evangelic Hospital, Klinikum Osnabruck, University Hospital Wurzburg, Chefarzi Zentrum Fur Vaskulare Neurologie und Intensivmedizin, Vivantes Hospital Neukolln, Johannes Wesling Klinikum Minden, Kepler Universitatsklinikum, Medical University of Graz, Landesklinikum Baden-Mödling, Landesklinikum Wiener Neustadt, Christian Doppler Klinik, Universitätsklinikum Tulln, Krankenhaus Barmherzige Brüder Eisenstadt, Stroke Center Rigshospitalet, Bispebjerg Hospital, Slagelse Hospital, Odense Universitetshospital, Herlev Hospital, Odense University Hospital and University Hospital RWTH have been removed from the study participating centres and Royal Bournemouth General Hospital, Fairfield General Hospital, King's Mill Hospital, University Hospital Llandough, Dorset County Hospital, Royal Infirmary of Edinburgh at Little France, Leeds General Infirmary, West Suffolk Hospital, Leighton Hospital and Ninewells Hospital have been added.
21/04/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/04/2022 to 03/05/2022.
2. The recruitment end date has been changed from 29/02/2024 to 30/11/2024.
15/03/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer reviewed).
2. Ethics approval details and trial website added.
3. The recruitment start date was changed from 01/03/2022 to 01/04/2022.
4. Contact details updated.
14/02/2022: The recruitment start date was changed from 01/02/2022 to 01/03/2022.
01/11/2021: The CPMS number was added.
05/10/2021: Trial's existence confirmed by the NIHR.
