| Source of record | UK Trials |
| ISRCTN | ISRCTN53885363 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0176079579 |
| Public title | The evaluation and treatment of cognitive symptoms in patients with multiple sclerosis (MS) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nervous System Diseases: Multiple sclerosis (MS) |
| Study hypothesis | 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 12 Healthy people. 24 Patients. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/11/2000 |
| Anticipated end date | 01/11/2003 |
| Status of trial | Completed |
| Target number of participants | 36 |
| Interventions | Randomised placebo controlled, single dose, crossover trial with MRI and behavioural endpoints. |
| Primary outcome measure(s) | 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 measure(s) | 1. Behavioural effect on other tasks within the neuropsychological battery
2. Possible side effects |
| Sources of funding | Oxford Radcliffe Hospitals NHS Trust |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Professor Paul M Matthews |
| Contact details | John Radcliffe Hospital
FMRIB Centre
Headley Way
Headington
Oxford
United Kingdom
OX3 9DU |
| Contact telephone | +44 01865 222493 |
| Contact fax | +44 01865 222717 |
| Contact email | paul@fmrib.ox.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN53885363 |
| Date last extracted from ISRCTN register | 17/04/2008 |
