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RECRUITING Not applicable ClinicalTrials.gov

Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

Sponsor: Danish Research Centre for Magnetic Resonance • ClinicalTrials.gov ID: NCT06569550

Registry updated: 2026-09-22
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Description

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

Interventions

  • Real Repetitive Transcranial Magnetic Stimulation (Device)
    Five sessions of real paired-pulse rTMS at 0.72Hz (inter-pulse interval of 30ms and inter-pair interval of 1381ms), for a total of 1300 pulse-pairs (30 minutes), across 5 sequential days, Monday to Friday. The stimulation is applied with a MagPro XP Orange stimulator (MagVenture A/S, Farum, Denmark), through a B65-Cool-A/P-CO coil (Magventure A/S) with an active and placebo (sham) side. The active side is an actively cooled figure-of-eight coil with an outer diameter of 65mm. Intensity is 80% of resting motor threshold. It is kept the same across all 5 sessions. The target is the left PMd, at MNI coordinates (34, -2, 66), transformed into patient space. Optimal coil placement, with respects to induced e-field at the target coordinates, is simulated with SimNIBS, based on the participants own MR images. The coil positioning is guided and monitored continuously with a neuronavigation system (Localite, Bonn, Germany) and the aid of robotic arm (Axilum Robotics, Schiltigheim, France ).
  • Sham Repetitive Transcranial Magnetic Stimulation (Device)
    Five sessions of real paired-pulse rTMS at 0.72Hz (inter-pulse interval of 30ms and inter-pair interval of 1381ms), for a total of 1300 pulse-pairs (30 minutes), across 5 sequential days, Monday to Friday. The stimulation is applied with a MagPro XP Orange stimulator (MagVenture A/S, Farum, Denmark), through a B65-Cool-A/P-CO coil (Magventure A/S) with an active and placebo (sham) side. The sham side does not deliver a magnetic pulse to the participant. The target is the left PMd, at MNI coordinates (34, -2, 66), transformed into patient space. Optimal coil placement, with respects to induced e-field at the target coordinates, is simulated with SimNIBS, based on the participants own MR images. The coil positioning is guided and monitored continuously with a neuronavigation system (Localite, Bonn, Germany) and the aid of robotic arm (Axilum Robotics, Schiltigheim, France ).

Eligibility criteria

Inclusion Criteria: * A confirmed diagnosis of relapse-remitting or secondary progressive multiple sclerosis, according to most recent McDonald's criteria (Thompson et al., 2018). This diagnosis must not be more recent than 3 months * Must have fatigue as a complaint, and an FSMC score corresponding to at least moderate fatigue (\>53) * Stable MS medication for at least 3 months Exclusion Criteria: * Pregnancy, any subject with the potential to become pregnant must ensure against this (e.g. by taking oral contraceptives, or other high efficacy method) * MS Relapse or steroid treatment within 3 months prior to inclusion * Current treatment targeted towards fatigue, or previous if discontinued within 3 months prior to inclusion * History of neurologic disease or other significant medical conditions, aside from MS * EDSS \> 6.5 * Major psychiatric disorder, including current clinical depression. * Intake of medication that primarily acts on CNS or neurotransmission, except SSRI or SNRI * Pacemaker or other implanted electronic devices * Any intracranial metal * Any metallic implant incompatible with MR scanning * Claustrophobia * Either patient or their close relatives suffering from epilepsy * Current Drug or alcohol abuse

Conditions

Multiple Sclerosis, Relapsing-Remitting Fatigue

Locations

  • Danish Research Centre for Magnetic Resonance — Hvidovre, Capital Region, Denmark
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record