Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
Overview
- Phase
- Phase 2
- Intervention
- 3,4-diaminopyridine
- Conditions
- Multiple Sclerosis
- Sponsor
- University of Aarhus
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Subjective fatigue (FSS)
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes.
Detailed Description
Only recruiting from: Department of Neurology, Aarhus University Hospital, Denmark
Investigators
Eligibility Criteria
Inclusion Criteria
- •Relapsing remitting-multiple sclerosis (RR-MS) according to Poser criteria
- •EDSS: max 3.5
- •Right handed
- •Normal function of the right hand
Exclusion Criteria
- •Disease interfering with MS
- •Known dementia
- •Drug or alcohol abuse
- •Treatment with psychoactive drugs within one week before study entry
- •Major changes of medical treatment within 3 weeks before study entry
- •Attack within 4 weeks before study entry
- •Pregnancy
- •Conditions interfering with 3,4-diaminopyridine treatment
- •Conditions interfering with MRI
- •Conditions interfering with transcranial magnetic stimulation
Arms & Interventions
3.4 diaminopyridine
Single dose 3,4 diaminopyridine
Intervention: 3,4-diaminopyridine
Placebo
Two tablets identical to active treatment
Intervention: Placebo
Outcomes
Primary Outcomes
Subjective fatigue (FSS)
Time Frame: Weeks
Maximal voluntary isometric contraction, central activation before and after exercise
Time Frame: at the time of investigation
Digit Symbol-Coding scores
Time Frame: Weeks
Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
Time Frame: at the time of MRI
Cortical atrophy
Time Frame: at the time of MRI
Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
Time Frame: at the time of investigation
Secondary Outcomes
- 6 minute walk test(at the time of investigation)
- Subjective fatigue (MFI-20, Danish version)(Weeks)
- Rapid voluntary twitches(at the time of investigation)
- 9-hole peg test(at the time of investigation)
- WAIS/WMS tests(at the time of investigation)
- WHO-5 Questionnaire(at the time of investigation)
- Major Depression Inventory(at the time of investigation)
- Lesion load(at the time of MRI)
- Whole brain atrophy(at the time of MRI)
- Subjective fatigue (VAS)(at the time of investigation)