Condition category
Circulatory System
Date applied
01/04/2015
Date assigned
02/04/2015
Last edited
16/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emilia Michou

ORCID ID

Contact details

University of Manchester
Clinical Sciences Building,Dept. of GI Sciences
Hope Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18688

Study information

Scientific title

Randomised controlled dose response trial of transcranial direct current stimulation for dysphagia after acute stroke

Acronym

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

12/NW/0262

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Stroke; Subtopic: Acute Care, Rehabilitation; Disease: Device used, Therapy type

Intervention

Dose response of transcranial direct current stimulation

Intervention type

Device

Phase

Drug names

Primary outcome measures

Changes in safety of swallowing based on formal assessments

Secondary outcome measures

N/A

Overall trial start date

01/04/2015

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 45; UK Sample Size: 45

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

United Kingdom

Trial participating centre

University of Manchester
Clinical Sciences Building,Dept. of GI Sciences Hope Hospital Stott Lane Salford
Greater Manchester
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/02/2016: Plain English summary added.