| Source of record | UK Trials |
| ISRCTN | ISRCTN83103698 |
| Date ISRCTN assigned | 07/01/2003 |
| Local reference number(s) | G108/374 |
| Public title | Therapeutic application of neuro-stimulation in acute dysphagic stroke |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Acute dysphagic stroke |
| Study hypothesis | Establish efficacy of pharyngeal stimulation in accelerating swallowing recovery after acute dysphagic stroke |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Hemispheric stroke and dysphagia |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/09/2003 |
| Anticipated end date | 31/08/2005 |
| Status of trial | Completed |
| Target number of participants | 80 |
| Interventions | Real versus sham stimulation |
| Primary outcome measure(s) | 1. Mortality
2. Aspiration pneumonia
3. Swallowing function assessed by videofluoroscopy |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Preliminary observations: 1. Gastroenterology 2005; 128, 4 (Suppl2): A-376. 2 Gut 2006; 55 (Supplement 2): A2.1
|
| Sources of funding | 1. Medical Research Council
2. The Health Foundation (Ref 1727/1793) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr S Hamdy |
| Contact details | GI Sciences
Hope Hospital
Eccles Old Road
Salford
United Kingdom
M6 8HD |
| Contact telephone | +44 (0)161 787 4414 |
| Contact fax | +44 (0)161 787 1495 |
| Contact email | Shaheen.hamdy@manchester.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN83103698 |
| Date last extracted from ISRCTN register | 17/04/2008 |
