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

Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
CompletedPhase 2Relapsing MSNCT00342381

What it found

No result found

We found no results in the registry or in papers.

This trial finished 18 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Amifampridine

    Voltage-gated potassium channel blocker

Placebo or sham

  • Placebo

What it measured

Main measures

  • Subjective fatigue (FSS)

    Weeks

    Fatigue

  • Maximal voluntary isometric contraction, central activation before and after exercise

    at the time of investigation

    Physical function

  • 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

    MRI lesions

  • Cortical atrophy

    at the time of MRI

    Brain volume loss

  • Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)

    at the time of investigation

Other measures (10)

  • Subjective fatigue (MFI-20, Danish version)

    Weeks

    Fatigue

  • Rapid voluntary twitches

    at the time of investigation

  • 6 minute walk test

    at the time of investigation

    Walking and mobility

  • 9-hole peg test

    at the time of investigation

    Disability progression

  • WAIS/WMS tests

    at the time of investigation

  • WHO-5 Questionnaire

    at the time of investigation

  • Major Depression Inventory

    at the time of investigation

    Mood and sleep

  • Lesion load

    at the time of MRI

    MRI lesions

  • Whole brain atrophy

    at the time of MRI

    Brain volume loss

  • Subjective fatigue (VAS)

    at the time of investigation

    Fatigue

Who could take part

Relapsing MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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Related trials

History

    1. Started

      Jun 2006

    2. Finished

      Dec 2007

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