Actively Recruiting
Led by Danish Research Centre for Magnetic Resonance · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
D
Danish Research Centre for Magnetic Resonance
Lead Sponsor
D
Danish Multiple Sclerosis Center
Collaborating Sponsor
Researchers are investigating whether repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left premotor cortex can reduce fatigue in patients with Multiple Sclerosis (MS) and if this approach is feasible as a treatment. The study also aims to better understand fatigue in MS by comparing real rTMS with sham (inactive) rTMS. The primary focus is to see if rTMS decreases fatigue symptoms and changes brain activity balance in the targeted area. Participants will receive either real or sham rTMS for 30 minutes daily over five consecutive days, Monday through Friday. The treatment uses a specialized coil guided by MRI and robotic positioning to target the left dorsal premotor cortex. The study involves a baseline period, the intervention phase, and a follow-up period. Brain scans using ultra-high field MRI and neurophysiological tests are conducted at baseline, during, and after treatment to measure changes. During the study, participants will visit the clinic before treatment and six days after to undergo clinical testing, MRI scans, and neurophysiological measurements. They will keep a fatigue diary and wear an activity tracker before, during, and after intervention. Additional online questionnaires are completed one day and four weeks after treatment. The main outcome measured is the change in fatigue severity from baseline to six days after intervention, supported by brain imaging and other fatigue-related assessments. Safety and compliance are closely monitored throughout the trial.
CONDITIONS
Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo clinical testing, MRI scans, and wear a wrist accelerometer while filling out a fatigue diary to establish baseline measurements.
1 baseline visit (in-person)
Duration - 5 sequential days
Participants receive 5 daily sessions of repetitive transcranial magnetic stimulation (rTMS) targeting the left premotor cortex to alleviate fatigue symptoms.
5 daily visits (in-person)
Duration - 1 day
Participants undergo follow-up MRI scans and neurophysiological testing immediately after the last treatment session, while continuing to wear a wrist accelerometer and fill out a fatigue diary.
1 visit (in-person)
Duration - 6 days after last treatment to 28 days post treatment
Participants return for clinical testing, MRI scans, and complete electronic questionnaires to assess fatigue and fatiguability after treatment.
3 visits: at 6 days post treatment, 1 day post treatment, and 28 days post treatment (some visits may be electronic questionnaires)
Total: 1 location
1
Danish Research Centre for Magnetic Resonance
Hvidovre, Capital Region, Denmark, 2650
Actively Recruiting
H
Hartwig R Siebner, MD, DMSc
S
Sofus AD Nygaard, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sofus Nygaard, Mads Alexander Just Madsen, Vanessa Wiggermann...
https://pubmed.ncbi.nlm.nih.gov/41835064