Therapeutic application of neuro-stimulation in acute dysphagic stroke
| ISRCTN | ISRCTN83103698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83103698 |
| Secondary identifying numbers | G108/374 |
- Submission date
- 07/01/2003
- Registration date
- 07/01/2003
- Last edited
- 03/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr S Hamdy
Scientific
Scientific
GI Sciences
Hope Hospital
Eccles Old Road
Salford
M6 8HD
United Kingdom
| Phone | +44 (0)161 787 4414 |
|---|---|
| Shaheen.hamdy@manchester.ac.uk |
Study information
| Study design | Randomised controlled 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 below to request a patient information sheet |
| Scientific title | A randomised controlled trial of pharyngeal electrical stimulation in the treatment of dysphagia after brain injury |
| Study hypothesis | Establish efficacy of pharyngeal stimulation in accelerating swallowing recovery after acute dysphagic stroke. On 22/07/2008 the following changes were made to the trial record: 1. The anticipated start date was changed from 01/09/2003 to 08/11/2005. 2. The anticipated end date was changed from 31/08/2005 to 31/11/2013. 3. The sources of funding field was changed from 'Medical Research Council (UK) and The Health Foundation (UK) (ref: 1727/1793)' to 'Action Medical Research (UK) (until April 2009) and National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)'. On 15/10/2009 the following changes were made to the trial record: 1. The scientific title was added. 2. The sources of funding field was changed from 'Action Medical Research (UK) (until April 2009) and National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) ' to 'National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)'. |
| Ethics approval(s) | Salford and Trafford Research Ethics Committee, 01/10/2002, ref: 00167. An ethics amendment for the current phase of the study was approved on 08/11/2005. |
| Condition | Acute dysphagic stroke |
| Intervention | Current interventions as of 05/09/2008: Subjects are randomised to receive either real or sham pharyngeal electrical stimulation at low frequency. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. Subjects receive the intervention three times in a week, within a few days following index videofluoroscopy. Previous interventions: Real versus sham stimulation The previous sponsor for this trial (from 01/09/2005 to 31/01/2008) was: Medical Research Council (UK) 20 Park Crescent London W1B 1AL United Kingdom |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 05/09/2008: Penetration-aspiration score and swallowing response time, assessed by videofluoroscopy at baseline and 2 weeks after the intervention. Previous primary outcome measures: 1. Mortality 2. Aspiration pneumonia 3. Swallowing function assessed by videofluoroscopy |
| Secondary outcome measures | Added as of 05/09/2008: 1. Aspiration pneumonia rates 2. Usage of antibiotics for chest infections 3. Hospital stays 4. Readmission rates 5. Mortality Total duration of follow-up: 6 months |
| Overall study start date | 08/11/2005 |
| Overall study end date | 30/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | Current inclusion criteria as of 05/09/2008: Any patient with first event of an anterior circulation stroke (both males and females, no age limits). Patients are recruited within 3 weeks of their admission with stroke. Videofluoroscopy is carried out to determine the degree of airway penetration/aspiration. Previous inclusion criteria: Hemispheric stroke and dysphagia |
| Participant exclusion criteria | 1. Inability to give informed consent 2. Serious inter-current illness 3. Major neuromuscular modulating drugs 4. Other neurological diseases 5. Previous dysphagia |
| Recruitment start date | 08/11/2005 |
| Recruitment end date | 30/11/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GI Sciences
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
University Research Office
2nd Floor Chrisie Building
University of Manchester
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Website | http://www.manchester.ac.uk |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | abstract from Annual Meeting of the American Gastroenterological Association/Digestive Disease Week: | 01/04/2005 | No | No | |
| Abstract results | abstract from Annual Meeting of the British Society of Gastroenterology: | 01/04/2006 | No | No |
