The evaluation and treatment of cognitive symptoms in patients with multiple sclerosis (MS)
| ISRCTN | ISRCTN53885363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53885363 |
| Secondary identifying numbers | N0176079579 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul M Matthews
Scientific
Scientific
John Radcliffe Hospital
FMRIB Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 222493 |
|---|---|
| paul@fmrib.ox.ac.uk |
Study information
| Study design | Randomised placebo controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. To examine the relationship between magnetic resonance imaging (MRI) indices and the severity of cognitive symptoms (e.g. poor memory and concentration) 2. To evaluate whether Rivastigmine Tartrate has a beneficial effect on the cognitive performance of patients with MS |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Multiple sclerosis (MS) |
| Intervention | Randomised placebo controlled, single dose, crossover trial with MRI and behavioural endpoints. |
| Intervention type | Other |
| Primary outcome measure | 1. Behavioural data during performance of the functional imaging task and in the formal cognitive assessment 2. Absolute measures of signal intensity change in regions of interest in the functional scan 3. Lesion load on T1 and T2 weighted MRI scans 4. The percentage of the white matter in the patient that has T1 values greater than normal |
| Secondary outcome measures | 1. Behavioural effect on other tasks within the neuropsychological battery 2. Possible side effects |
| Overall study start date | 01/11/2000 |
| Completion date | 01/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Key inclusion criteria | 12 Healthy people. 24 Patients. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 01/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2003 | Yes | No |
