Condition category
Signs and Symptoms
Date applied
10/11/2006
Date assigned
04/12/2006
Last edited
08/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 below 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 measures

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

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

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

08/09/2016: Publication references added. 07/09/2016: The overall trial end date was changed from 30/07/2009 to 14/01/2010.