Imaging the neural correlates of rehabilitation in Wernicke's aphasia
| ISRCTN | ISRCTN68939136 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68939136 |
| Clinical Trials Information System (CTIS) | 2005-004215-30 |
| Protocol serial number | 075765; ME033459MES |
| Sponsor | Joint UCLH and UCL Biomedical Research Unit (UK) |
| Funder | Wellcome Trust (grant ref: 075765) |
- Submission date
- 10/11/2006
- Registration date
- 04/12/2006
- Last edited
- 06/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Around one in three people experience some degree of aphasia after having a stroke. Aphasia is caused by damage to parts of the brain responsible for understanding and using language. In Wernicke's aphasia, a person is able to speak normally and use long, complex sentences, but the actual words they use do not make sense, or they include nonsense words in their speech. The aim of this study is to measure therapy-related changes in brain function in a group of patients with post-stroke Wernicke's aphasia. Two therapies will be trialled: a drug (donepezil) and a computer-delivered speech therapy programme.
Who can participate?
Men and women over the age of 18 with Wernicke's aphasia who had a stroke more than three months ago.
What does the study involve?
Each patient will be randomly allocated to one of two groups. Group one will take donezepil once daily for five weeks; if this is well tolerated then the dose will be increased. Group two will take a placebo (dummy). After a five-week break, group one will take the placebo and group two will take donezepil. A five-week behavioural therapy treatment will also be provided to both groups, which will be performed by the patients at their home and will consist of 30 minutes of a computer-based speech therapy programme once a day.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Wellcome Department of Imaging Neuroscience (UK)
When is the study starting and how long is it expected to run for?
October 2006 to January 2010
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Dr Alexander Paul Leff
a.leff@fil.ion.ucl.ac.uk
Contact information
Scientific
Wellcome Department of Imaging Neuroscience
12 Queen Square
London
WC1N 3BG
United Kingdom
 ORCID ID |
0000-0002-0831-3541 |
|---|---|
| Phone | +44 (0)20 7833 7472 |
| a.leff@fil.ion.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blinded cross-over randomised controlled trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Imaging the neural correlates of cholinergic and behaviour driven rehabilitation in patients with Wernicke's aphasia: a double-blinded, cross-over, randomised controlled trial |
| Study objectives | 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. |
| Ethics approval(s) | National Hospital for Neurology and Neurosurgery and the Institute of Neurology Joint REC, 06/01/2006, ref: 05/Q0512/134 |
| Health condition(s) or problem(s) studied | Post-stroke aphasia |
| Intervention | 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. |
| Intervention type | Mixed |
| 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. |
| Key secondary outcome measure(s) |
Correlation between treatment type and improvements on a language rating scale: the Comprehensive Aphasia Test. |
| Completion date | 14/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Subjects will be English native speakers 2. Subjects will be over the age of 18, either sex 3. More than three months post stroke 4. Only consent competent patients will be enrolled |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 30/07/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
WC1N 3BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2017 | Yes | No | |
| Other publications | baseline data | 01/06/2011 | Yes | No | |
| Other publications | baseline data | 21/03/2012 | Yes | No | |
| Other publications | baseline data | 01/06/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/03/2017: Publication references added.
08/09/2016: Publication references added.
07/09/2016: The overall trial end date was changed from 30/07/2009 to 14/01/2010.
