search
Back to results

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

Primary Purpose

Multiple Sclerosis, Fatigue

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
3,4-diaminopyridine
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Motor fatigue, Cognitive fatigue

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University Hospital, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

3.4 diaminopyridine

Placebo

Arm Description

Single dose 3,4 diaminopyridine

Two tablets identical to active treatment

Outcomes

Primary Outcome Measures

Subjective fatigue (FSS)
Maximal voluntary isometric contraction, central activation before and after exercise
Digit Symbol-Coding scores
Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
Cortical atrophy
Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)

Secondary Outcome Measures

Subjective fatigue (MFI-20, Danish version)
Rapid voluntary twitches
6 minute walk test
9-hole peg test
WAIS/WMS tests
WHO-5 Questionnaire
Major Depression Inventory
Lesion load
Whole brain atrophy
Subjective fatigue (VAS)

Full Information

First Posted
June 20, 2006
Last Updated
December 12, 2007
Sponsor
University of Aarhus
Collaborators
The Danish Multiple Sclerosis Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00342381
Brief Title
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

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
The Danish Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Fatigue
Keywords
Motor fatigue, Cognitive fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3.4 diaminopyridine
Arm Type
Active Comparator
Arm Description
Single dose 3,4 diaminopyridine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two tablets identical to active treatment
Intervention Type
Drug
Intervention Name(s)
3,4-diaminopyridine
Intervention Description
Single dose 3,4 diaminopyridine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
n/d
Intervention Description
Single dose placebo treatment
Primary Outcome Measure Information:
Title
Subjective fatigue (FSS)
Time Frame
Weeks
Title
Maximal voluntary isometric contraction, central activation before and after exercise
Time Frame
at the time of investigation
Title
Digit Symbol-Coding scores
Time Frame
Weeks
Title
Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
Time Frame
at the time of MRI
Title
Cortical atrophy
Time Frame
at the time of MRI
Title
Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
Time Frame
at the time of investigation
Secondary Outcome Measure Information:
Title
Subjective fatigue (MFI-20, Danish version)
Time Frame
Weeks
Title
Rapid voluntary twitches
Time Frame
at the time of investigation
Title
6 minute walk test
Time Frame
at the time of investigation
Title
9-hole peg test
Time Frame
at the time of investigation
Title
WAIS/WMS tests
Time Frame
at the time of investigation
Title
WHO-5 Questionnaire
Time Frame
at the time of investigation
Title
Major Depression Inventory
Time Frame
at the time of investigation
Title
Lesion load
Time Frame
at the time of MRI
Title
Whole brain atrophy
Time Frame
at the time of MRI
Title
Subjective fatigue (VAS)
Time Frame
at the time of investigation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Andersen, MD, DMSc
Organizational Affiliation
Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johannes Jacobsen, Professor
Organizational Affiliation
Aarhus University Hospital, Aarhus, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Department of Neurology
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs