Clinical trial NCT00342381: Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation
Official title: Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Fatigue
Keywords: Motor fatigue
Cognitive fatigue
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Multiple Sclerosis Society
First posted: 2006-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Subjective fatigue (FSS)
timeFrame: Weeks
measure: Maximal voluntary isometric contraction, central activation before and after exercise
timeFrame: at the time of investigation
measure: Digit Symbol-Coding scores
timeFrame: Weeks
measure: Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
timeFrame: at the time of MRI
measure: Cortical atrophy
timeFrame: at the time of MRI
measure: Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
timeFrame: at the time of investigation
Secondary outcomes:
measure: Subjective fatigue (MFI-20, Danish version)
timeFrame: Weeks
measure: Rapid voluntary twitches
timeFrame: at the time of investigation
measure: 6 minute walk test
timeFrame: at the time of investigation
measure: 9-hole peg test
timeFrame: at the time of investigation
measure: WAIS/WMS tests
timeFrame: at the time of investigation
measure: WHO-5 Questionnaire
timeFrame: at the time of investigation
measure: Major Depression Inventory
timeFrame: at the time of investigation
measure: Lesion load
timeFrame: at the time of MRI
measure: Whole brain atrophy
timeFrame: at the time of MRI
measure: Subjective fatigue (VAS)
timeFrame: at the time of investigation
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Neurology
Study officials:
affiliation: Aarhus University Hospital
name: Henning Andersen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Johannes Jacobsen, Professor
role: STUDY_CHAIR
References: