Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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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
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Only recruiting from: Department of Neurology, Aarhus University Hospital, Denmark

Official Title
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Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation

Conditions
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Multiple Sclerosis, Fatigue

Intervention / Treatment
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* Drug: 3,4-diaminopyridine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3.4 diaminopyridine<br>Single dose 3,4 diaminopyridine | Drug: 3,4-diaminopyridine<br>* Single dose 3,4 diaminopyridine<br>|
| Placebo Comparator: Placebo<br>Two tablets identical to active treatment | Drug: Placebo<br>* Single dose placebo treatment<br>* Other names: n/d;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective fatigue (FSS) |  | Weeks | 
| Maximal voluntary isometric contraction, central activation before and after exercise |  | at the time of investigation | 
| Digit Symbol-Coding scores |  | Weeks | 
| Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters) |  | at the time of MRI | 
| Cortical atrophy |  | at the time of MRI | 
| Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine) |  | at the time of investigation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective fatigue (MFI-20, Danish version) |  | Weeks | 
| Rapid voluntary twitches |  | at the time of investigation | 
| 6 minute walk test |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor fatigue, Cognitive fatigue