Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06569550

Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

Led by Danish Research Centre for Magnetic Resonance · Updated on 2026-01-28

60

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

Sponsors

D

Danish Research Centre for Magnetic Resonance

Lead Sponsor

D

Danish Multiple Sclerosis Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS) of the left premotor cortex can lessen fatigue in patients with Multiple Sclerosis, and if this is a feasible intervention. It will also give further information on fatigue in Multiple Sclerosis. The main questions it aims to answer is: * Does premotor rTMS decrease fatigue symptoms in patients with Multiple Sclerosis? * Is the change in fatigue reflected in an altered balance between brain excitation and inhibition in the targeted premotor cortex? Researchers will compare real rTMS with sham rTMS (which does not stimulate with a magnetic field), to see if real rTMS works to alleviate fatigue. Participants will: * Receive real or sham rTMS for 30 minutes, 5 days in a row * Visit the clinic before and 6 days after for baseline and follow-up * Fill out on-line questionnaires 1 day and 4 weeks after the end of intervention * Undergo a total of 3 brain scans (Magnetic Resonance Imaging at ultra-high field), at baseline, end of intervention, and follow-up * Undergo lab neurophysiological measurements before and after the first intervention session * Keep a fatigue diary and wear an activity tracker in the period before and after the intervention

CONDITIONS

Official Title

Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of relapsing-remitting or secondary progressive multiple sclerosis according to recent criteria, diagnosed at least 3 months ago
  • Fatigue complaint with a Fatigue Scale for Motor and Cognitive Symptoms (FSMC) score indicating moderate or greater fatigue (>53)
  • Stable multiple sclerosis medication for at least 3 months
Not Eligible

You will not qualify if you...

  • Pregnancy or potential pregnancy without high efficacy contraception
  • Multiple sclerosis relapse or steroid treatment within 3 months before joining
  • Current or recent (within 3 months) treatment specifically targeting fatigue
  • History of neurological diseases or other major medical conditions besides MS
  • Expanded Disability Status Scale (EDSS) score greater than 6.5
  • Major psychiatric disorders including current clinical depression
  • Use of medications primarily affecting the central nervous system except SSRIs or SNRIs
  • Presence of pacemakers or other implanted electronic devices
  • Any intracranial metal or metallic implants incompatible with MRI
  • Claustrophobia
  • Personal or close family history of epilepsy
  • Current drug or alcohol abuse

AI-Screening

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Trial Site Locations

Total: 1 location

1

Danish Research Centre for Magnetic Resonance

Hvidovre, Capital Region, Denmark, 2650

Actively Recruiting

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Research Team

H

Hartwig R Siebner, MD, DMSc

CONTACT

S

Sofus AD Nygaard, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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