Imaging the neural correlates of rehabilitation in Wernicke's aphasia

ISRCTN ISRCTN68939136
DOI https://doi.org/10.1186/ISRCTN68939136
EudraCT/CTIS number 2005-004215-30
Secondary identifying numbers 075765; ME033459MES
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Alexander Paul Leff
Scientific

Wellcome Department of Imaging Neuroscience
12 Queen Square
London
WC1N 3BG
United Kingdom

ORCiD logoORCID ID 0000-0002-0831-3541
Phone +44 (0)20 7833 7472
Email a.leff@fil.ion.ucl.ac.uk

Study information

Study designDouble-blinded cross-over randomised controlled trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleImaging the neural correlates of cholinergic and behaviour driven rehabilitation in patients with Wernicke's aphasia: a double-blinded, cross-over, randomised controlled trial
Study objectivesTo 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) studiedPost-stroke aphasia
InterventionThis 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 typeMixed
Primary outcome measureCorrelation 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 measuresCorrelation between treatment type and improvements on a language rating scale: the Comprehensive Aphasia Test.
Overall study start date01/10/2006
Completion date14/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants~30
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2006
Date of final enrolment30/07/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wellcome Department of Imaging Neuroscience
London
WC1N 3BG
United Kingdom

Sponsor information

Joint UCLH and UCL Biomedical Research Unit (UK)
Not defined

c/o Dr Victoria Latter, Operations Director
1st Floor, Maple House
149 Tottenham Court Road
London
W1P 9LL
United Kingdom

Phone +44 (0)20 7472 6394
Email v.latter@medsch.ucl.ac.uk
Website http://www.ucl.ac.uk/biomed-r-d/general/about_us.htm#contact
ROR logo "ROR" https://ror.org/03r9qc142

Funders

Funder type

Charity

Wellcome Trust (grant ref: 075765)
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date07/03/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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
Results article results 01/07/2017 Yes No

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.