Fatigue, Multiple Sclerosis
Conditions
Keywords
Motor fatigue, Cognitive fatigue
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
Interventions
Single dose 3,4 diaminopyridine
DRUGPlacebo
Single dose placebo treatment
Sponsors
The Danish Multiple Sclerosis Society
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cortical atrophy | at the time of MRI |
| Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters) | at the time of MRI |
| Subjective fatigue (FSS) | Weeks |
| Maximal voluntary isometric contraction, central activation before and after exercise | at the time of investigation |
| Digit Symbol-Coding scores | Weeks |
| Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine) | at the time of investigation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Subjective fatigue (MFI-20, Danish version) | Weeks |
Countries
Denmark
Outcome results
None listed