Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Danish Research Centre for Magnetic Resonance
Hvidovre, Capital Region, Denmark, 2650
Actively Recruiting
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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