Testing Repetitive Transcranial Magnetic Stimulation rTMS on the Left Premotor Cortex to Reduce Fatigue in Adults with Multiple Sclerosis
Led by Danish Research Centre for Magnetic Resonance · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
Research Team
H
Hartwig R Siebner, MD, DMSc
S
Sofus AD Nygaard, MD
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Confirmed diagnosis of relapsing-remitting or secondary progressive multiple sclerosis according to recent McDonald's criteria, diagnosed more than 3 months ago
Experiencing fatigue with a Fatigue Scale for Motor and Cognitive Symptoms (FSMC) score indicating at least moderate fatigue (>53)
Stable multiple sclerosis medication for at least 3 months
You will not qualify if you...
Pregnancy or potential to become pregnant without effective contraception
Multiple sclerosis relapse or steroid treatment within the past 3 months
Current or recent (within 3 months) treatment specifically targeting fatigue
History of neurological diseases other than multiple sclerosis or other significant medical conditions
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 or neurotransmission, except SSRIs or SNRIs
Presence of pacemaker or other implanted electronic devices
Any intracranial metal implants
Metallic implants incompatible with MRI scanning
Claustrophobia
Patient or close relatives with epilepsy
Current drug or alcohol abuse
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
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)
Treatment
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)
Immediate Post-Treatment Assessment
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)
Follow-up
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)
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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Published Research Related To This Trial
Repetitive transcranial magnetic stimulation to alleviate fatigue in multiple sclerosis-study protocol for a randomized sham-controlled double-blinded clinical trial.
Sofus Nygaard, Mads Alexander Just Madsen, Vanessa Wiggermann...