The evaluation and treatment of cognitive symptoms in patients with multiple sclerosis (MS)

ISRCTN	ISRCTN53885363
DOI	https://doi.org/10.1186/ISRCTN53885363
Protocol serial number	N0176079579
Sponsor	Department of Health (UK)
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Paul M Matthews
Scientific

John Radcliffe Hospital
FMRIB Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 222493
Email	paul@fmrib.ox.ac.uk

Primary study design	Interventional
Study design	Randomised placebo controlled crossover group trial
Secondary study design	Randomised controlled trial
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(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
Key secondary outcome measure(s)	1. Behavioural effect on other tasks within the neuropsychological battery 2. Possible side effects
Completion date	01/11/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2003		Yes	No