Non-invasive brain stimulation for dysphagia after acute stroke
| ISRCTN | ISRCTN97286108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97286108 |
| Secondary identifying numbers | 18688 |
- Submission date
- 01/04/2015
- Registration date
- 02/04/2015
- Last edited
- 28/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A stroke occurs when the blood supply to part of the brain is cut off. Around one in two stroke sufferers will have difficulties with swallowing which can complicate their recovery and reduces quality of life. Swallowing problems happen when the part of the brain that controls swallowing is injured by the stroke itself. Swallowing recovers naturally in a proportion of people when the healthy side of the brain adapts and takes over the control of swallowing. There is new evidence that stimulating the healthy side of the brain can speed up this natural recovery process (called plasticity). The aim of this study is to find out if low current brain stimulation to the healthy side of the brain can speed up swallowing recovery and improve quality of life after stroke, and to establish the most effective dose of the treatment.
Who can participate?
Patients having difficulty swallowing (dysphagia) after having suffered a stroke
What does the study involve?
Not provided at time of registration
What are the possible benefits and risks of participating?
The results of this study will provide evidence for using this new approach for dysphagia rehabilitation. The expectation is that this portable user-friendly non-invasive stimulation will be rapidly rolled out into a larger study for use in rehabilitation and lead into changes in practice at a national level in the NHS.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
April 2015 to September 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Emilia Michou
Emilia.Michou@manchester.ac.uk
Contact information
Scientific
University of Manchester
Clinical Sciences Building,Dept. of GI Sciences
Hope Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom
| Phone | +44 (0)161 2061510 |
|---|---|
| Emilia.Michou@manchester.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Randomised controlled dose response trial of transcranial direct current stimulation for dysphagia after acute stroke |
| Study hypothesis | The aim of this research project is to find out if low current brain stimulation to the healthy side of the brain in stroke patients with dysphagia can speed up swallowing recovery and improve quality of life after their stroke and to establish the most effective dose of the treatment. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=18688 |
| Ethics approval(s) | 12/NW/0262 |
| Condition | Topic: Stroke; Subtopic: Acute Care, Rehabilitation; Disease: Device used, Therapy type |
| Intervention | Dose response of transcranial direct current stimulation |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Changes in safety of swallowing based on formal assessments |
| Secondary outcome measures | N/A |
| Overall study start date | 01/04/2015 |
| Overall study end date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 45; UK Sample Size: 45 |
| Participant inclusion criteria | 1. All patients with dysphagia following acute anterior or posterior cerebral circulation stroke that present dysphagia for the first time, within the first weeks from symptoms and up to 6 weeks post stroke. The presence of dysphagia will be based on the results of screening procedures by the research team. Patients will be always recruited after 48-72 hours post lesion 2. There is no age limit 3. Patients must be medically stable 4. Lesions have to be verified on imaging techniques, either magnetic resonance (MR) scan or computerised tomography (CT), information which will be collected |
| Participant exclusion criteria | 1. Advanced dementia 2. Other neurological conditions that may explain swallowing difficulty (dysphagia) 3. Previous history of dysphagia 4. Presence of cardiac pacemaker of implanted cardiac defibrillator 5. Any metal in the head or eyes 6. Use of medication which decreases seizure threshold 7. A diagnosis other than stroke is suspected (e.g. brain tumour) 8. Any severe concomitant chronic medical condition that compromises cardiac or respiratory status, 9. Significant structural abnormalities of the mouth or throat 10. Patients requiring oxygen treatment will be excluded at point of entry to prevent further compromise to already impaired respiratory system 11. Patients may be reconsidered for recruitment if they are successfully weaned off oxygen treatment |
| Recruitment start date | 01/04/2015 |
| Recruitment end date | 01/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hope Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom
Sponsor information
University/education
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/02/2016: Plain English summary added.
