|
Welcome
|
|
12 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| Therapeutic application of neuro-stimulation in acute dysphagic stroke |
| ISRCTN | ISRCTN83103698 |
| ClinicalTrials.gov identifier | |
| Public title | Therapeutic application of neuro-stimulation in acute dysphagic stroke |
| Scientific title | A randomised controlled trial of pharyngeal electrical stimulation in the treatment of dysphagia after brain injury |
| Acronym | N/A |
| Serial number at source | G108/374 |
| Study hypothesis |
Establish efficacy of pharyngeal stimulation in accelerating swallowing recovery after acute dysphagic stroke.
Please note that, as of 22/07/2008, the start and end dates of this trial have been updated from 01/09/2003 and 31/08/2005 to 08/11/2005 and 31/11/2013, respectively. Please note that the scientific title was added as of 19/10/2009. |
| Lay summary | |
| Ethics approval | Salford and Trafford Research Ethics Committee (ref: 00167). Original ethics approval date: 01/10/2002. An ethics amendment for the current phase of the study was approved on 08/11/2005. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acute dysphagic stroke |
| Participants - 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 |
| 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 |
| Anticipated start date | 08/11/2005 |
| Anticipated end date | 30/11/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
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 3 times in a week, within a few days following index videofluoroscopy. Previous interventions: Real versus sham stimulation 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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding |
Current source of funding as of 15/10/2009:
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Current sources of funding as of 22/07/2008: 1. Action Medical Research (UK) (until April 2009) 2. National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Previous sources of funding: 1. Medical Research Council (UK) 2. The Health Foundation (UK) (ref: 1727/1793) |
| Trial website | |
| Publications |
1. 2005 abstract from Annual Meeting of the American Gastroenterological Association/Digestive Disease Week: http://www.ncbi.nlm.nih.gov/pubmed/15900640
2. 2006 abstract from Annual Meeting of the British Society of Gastroenterology: http://www.ncbi.nlm.nih.gov/pubmed/16531518 |
| Contact name | Dr S Hamdy |
| Address |
GI Sciences
Hope Hospital Eccles Old Road |
| City/town | Salford |
| Zip/Postcode | M6 8HD |
| Country | United Kingdom |
| Tel | +44 (0)161 787 4414 |
| Fax | +44 (0)161 787 1495 |
| Shaheen.hamdy@manchester.ac.uk | |
| Sponsor | University of Manchester (UK) |
| Address |
University Research Office
2nd Floor Chrisie Building University of Manchester Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9PL |
| Country | United Kingdom |
| Sponsor website: | http://www.manchester.ac.uk |
| Date applied | 07/01/2003 |
| Last edited | 19/10/2009 |
| Date ISRCTN assigned | 07/01/2003 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|