| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN68939136 |
| Date ISRCTN assigned | 04/12/2006 |
| Local reference number(s) | 075765; ME033459MES |
| Public title | Imaging the neural correlates of cholinergic and behaviour driven rehabilitation in patients with Wernicke's aphasia |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Post-stroke aphasia |
| Study hypothesis | To measure therapy related changes in brain function in a group of patients with post-stroke, Wernicke's aphasia. Two therapies will be trialed: a drug (donepezil) and computer delivered speech therapy programme. |
| Design/methodology | A double-blinded, cross-over, randomised controlled trial |
| Research ethics review | Approval received from the local COREC committee (National Hospital for Neurology and Neurosurgery and the Institute of Neurology Joint REC) on the 6th January 2006 (ref: 05/Q0512/134). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Subjects will be English native speakers
2. Subjects will be over the age of 18
3. More than three months post stroke
4. Only consent competent patients will be enrolled |
| Participants - exclusion criteria | 1. Patients with contraindications to cholinesterase inhibitors
2. Patients with contraindications to functional Magnetic Resonance Imaging (fMRI)/Magnetoencephalography (MEG)
3. Significant medical or psychiatric co-morbidity
4. Under 18 years old |
| Patient information material |
|
| Anticipated start date | 01/10/2006 |
| Anticipated end date | 30/07/2009 |
| Status of trial | Ongoing |
| Target number of participants | ~30 - Recruitment ends on the 30/11/2008 |
| Interventions | This is a cross-over trial. Each patient will be randomised to one of the two groups:
Group one: Donezepil (5 mg) once daily (od) for five weeks (block one), if this is well tolerated then this will be increased to 10 mg od for five weeks (block two).
Group two: An identical placebo will be provided, to be used in the exact same method as above (blocks four and five).
In between the two groups (block three), there will be a washout period of five weeks.
At blocks two and five, a non drug intervention will also be supplied. During these times, a five week Behavioural Therapy (BT) treatment will also be provided, which will be performed by the patients at their home, and will consist of 30 minutes of a computer-based phonological training program once a day. |
| Primary outcome measure(s) | Correlation between treatment type and changes in the response characteristics of a neurophysiologic measure of auditory discrimination (Mismatch Negativity [MMN]), provoked by language and non-language stimuli, measured using both MEG and fMRI. |
| Secondary outcome measure(s) | Correlation between treatment type and improvements on a language rating scale: the Comprehensive Aphasia Test. |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 075765) - Intermediate Clinical Fellowship |
| Sponsor name | Joint UCLH and UCL Biomedical Research Unit (UK) |
| Sponsor details | c/o Dr Victoria Latter, Operations Director
1st Floor, Maple House
149 Tottenham Court Road
London
United Kingdom
W1P 9LL |
| Sponsor telephone | +44 (0)20 7472 6394 |
| Sponsor email | v.latter@medsch.ucl.ac.uk |
| Sponsor website | http://www.ucl.ac.uk/biomed-r-d/general/about_us.htm#contact |
| Contact name | Dr Alexander Paul Leff |
| Contact details | Wellcome Department of Imaging Neuroscience
12 Queen Square
London
United Kingdom
WC1N 3BG |
| Contact telephone | +44 (0)20 7833 7472 |
| Contact fax | +44 (0)20 7833 7472 |
| Contact email | a.leff@fil.ion.ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68939136 |
| Date last extracted from ISRCTN register | 17/04/2008 |
