Electrical stimulation of the throat for swallowing difficulties after stroke

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

Study website

https://stroke.nottingham.ac.uk/pheast/

Type

Scientific

Contact name

Mr Philip Bath

ORCID ID

Contact details

Stroke Trials Unit
Mental Health & Clinical Neurosciences
University of Nottingham
D Floor
South Block
Room 2117
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 82 31768
philip.bath@nottingham.ac.uk

Type

Public

Contact name

Ms Gemma Squires

ORCID ID

Contact details

Stroke Trials Unit
Mental Health & Clinical Neurosciences
University of Nottingham
D Floor
South Block
Room 2151
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)82 31255
Gemma.Squires1@nottingham.ac.uk

EudraCT/CTIS number

Nil known

IRAS number

304658

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 304658, NIHR132016, CPMS 50913

Scientific title

Pharyngeal Electrical stimulation for Acute Stroke dysphagia Trial (PhEAST)

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

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

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

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

Reason abandoned (if study stopped)

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 type(s)

Patient

Age group

Mixed

Lower age limit

18 Years

Sex

Both

Target number of participants

800

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

Countries of recruitment

Austria, Denmark, England, Germany, Northern Ireland, Scotland, United Kingdom, Wales

Study participating centre

Aberdeen Royal Infirmary
Foresterhill Road
Aberdeen
AB25 2ZN
United Kingdom

Study participating centre

Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom

Study participating centre

Royal Victoria Hospital
274 Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Study participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study participating centre

The Queen Elizabeth Hospital
Gayton Road
King's Lynn
PE30 4ET
United Kingdom

Study participating centre

Royal London Hospital
Whitechapel Road
Whitechapel
London
E1 1BB
United Kingdom

Study participating centre

St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Study participating centre

Luton and Dunstable University Hospital
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Study participating centre

Queens Medical Centre
Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom

Study participating centre

Salford Royal Hospital
Stott Lane
Eccles
Salford
M6 8HD
United Kingdom

Study participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study participating centre

Stepping Hill Hospital
Stockport NHS Foundation Trust
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom

Study participating centre

Royal Stoke University Hospital
Newcastle Road
Stoke-on-trent
ST4 6QG
United Kingdom

Study participating centre

Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Study participating centre

Musgrove Park Hospital (taunton)
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

Study participating centre

Warrington Hospital (site)
Warrington Hospital
Lovely Lane
Warrington
WA5 1QG
United Kingdom

Study participating centre

Royal Bournemouth General Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Study participating centre

Fairfield General Hospital
Fairfield General Hospital
Rochdale Old Road
Bury
BL9 7TD
United Kingdom

Study participating centre

King's Mill Hospital
Mansfield Road
Mansfield
NG17 4JL
United Kingdom

Study participating centre

University Hospital Llandough
Penlan Road
Llandough
Penarth
CF64 2XX
United Kingdom

Study participating centre

Dorset County Hospital
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Study participating centre

Royal Infirmary of Edinburgh at Little France
51 Little France Crescent
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom

Study participating centre

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Study participating centre

West Suffolk Hospital
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom

Study participating centre

Leighton Hospital
Leighton
Crewe
CW1 4QJ
United Kingdom

Study participating centre

Ninewells Hospital
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom

Organisation

University of Nottingham

Sponsor details

Room East Atrium Jubilee Conference centre
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
England
United Kingdom
+44 (0)115 8467906
bb-sponsor@exmail.nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

ROR

https://ror.org/01ee9ar58

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

Phagenesis Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Intention to publish date

30/07/2026

Individual participant data (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.

IPD sharing plan summary

Available on request

Study outputs

• ISRCTN98886991_PROTOCOL_V2.0_02Dec2021.pdf