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Completed

NCT Number: NCT00342381

Fatigue in Multiple Sclerosis: Evaluated With 3 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, Department of Neurology

Aarhus, 8000, Denmark

About this study

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3,4-diaminopyridine

Drug

Single dose 3,4 diaminopyridine

Placebo

Drug

Single dose placebo treatment

Other names: n/d

Primary outcomes

  1. Subjective fatigue (FSS)

    Time frame: Weeks

  2. Maximal voluntary isometric contraction, central activation before and after exercise

    Time frame: at the time of investigation

  3. Digit Symbol-Coding scores

    Time frame: Weeks

  4. Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)

    Time frame: at the time of MRI

  5. Cortical atrophy

    Time frame: at the time of MRI

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

    Time frame: at the time of investigation

Secondary outcomes

  1. Subjective fatigue (MFI-20, Danish version)

    Time frame: Weeks

  2. Rapid voluntary twitches

    Time frame: at the time of investigation

  3. 6 minute walk test

    Time frame: at the time of investigation

  4. 9-hole peg test

    Time frame: at the time of investigation

  5. WAIS/WMS tests

    Time frame: at the time of investigation

  6. WHO-5 Questionnaire

    Time frame: at the time of investigation

  7. Major Depression Inventory

    Time frame: at the time of investigation

  8. Lesion load

    Time frame: at the time of MRI

  9. Whole brain atrophy

    Time frame: at the time of MRI

  10. Subjective fatigue (VAS)

    Time frame: at the time of investigation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Danish Multiple Sclerosis Society

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Jun 21, 2006
Registry last updated
Dec 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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