Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alexander Paul Leff
ORCID ID
http://orcid.org/0000-0002-0831-3541
Contact details
Wellcome Department of Imaging Neuroscience
12 Queen Square
London
WC1N 3BG
United Kingdom
+44 (0)20 7833 7472
a.leff@fil.ion.ucl.ac.uk
Additional identifiers
EudraCT number
2005-004215-30
ClinicalTrials.gov number
Protocol/serial number
075765; ME033459MES
Study information
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
Acronym
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.
Ethics approval
National Hospital for Neurology and Neurosurgery and the Institute of Neurology Joint REC, 06/01/2006, ref: 05/Q0512/134
Study design
Double-blinded cross-over randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
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 measures
Correlation between treatment type and improvements on a language rating scale: the Comprehensive Aphasia Test.
Overall trial start date
01/10/2006
Overall trial end date
14/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
~30
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
30/07/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wellcome Department of Imaging Neuroscience
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
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
W1P 9LL
United Kingdom
+44 (0)20 7472 6394
v.latter@medsch.ucl.ac.uk
Sponsor type
Not defined
Website
http://www.ucl.ac.uk/biomed-r-d/general/about_us.htm#contact
Funders
Funder type
Charity
Funder name
Wellcome Trust (grant ref: 075765)
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The main (longitudinal) result is in review and will be published in the next 6 months. Another paper (secondary outcomes) should be submitted in the next 6 months.
Intention to publish date
07/03/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2011 baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/21731479
2012 baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/22442088
2013 baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/23715097
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28259857