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

December 12, 2007 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3.4 diaminopyridine
Single dose 3,4 diaminopyridine
Drug: 3,4-diaminopyridine
Single dose 3,4 diaminopyridine
Placebo Comparator: Placebo
Two tablets identical to active treatment
Drug: Placebo
Single dose placebo treatment
Other Names:
  • n/d

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective fatigue (MFI-20, Danish version)
Time Frame: Weeks
Weeks
Rapid voluntary twitches
Time Frame: at the time of investigation
at the time of investigation
6 minute walk test
Time Frame: at the time of investigation
at the time of investigation
9-hole peg test
Time Frame: at the time of investigation
at the time of investigation
WAIS/WMS tests
Time Frame: at the time of investigation
at the time of investigation
WHO-5 Questionnaire
Time Frame: at the time of investigation
at the time of investigation
Major Depression Inventory
Time Frame: at the time of investigation
at the time of investigation
Lesion load
Time Frame: at the time of MRI
at the time of MRI
Whole brain atrophy
Time Frame: at the time of MRI
at the time of MRI
Subjective fatigue (VAS)
Time Frame: at the time of investigation
at the time of investigation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

The Danish Multiple Sclerosis Society

Investigators

  • Principal Investigator: Henning Andersen, MD, DMSc, Aarhus University Hospital, Aarhus, Denmark
  • Study Chair: Johannes Jacobsen, Professor, Aarhus University Hospital, Aarhus, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 20, 2006

First Submitted That Met QC Criteria

June 20, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Estimate)

December 17, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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