RecruitingNot ApplicableNCT06569550

Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

Neuromodulation of the Left Premotor Cortex With Transcranial Magnetic Stimulation to Alleviate Fatigue in Multiple Sclerosis - a Randomised Controlled Clinical Trial

Sponsor

Danish Research Centre for Magnetic Resonance

Enrollment

60 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Fatigue Multiple Sclerosis, Relapsing-Remitting

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a non-invasive brain stimulation technique called transcranial magnetic stimulation (TMS) — which uses magnetic pulses on the scalp — can reduce fatigue in people with multiple sclerosis (MS). Fatigue is one of the most common and disabling symptoms of MS, yet few effective treatments exist for it. **You may be eligible if:** - You have a confirmed diagnosis of relapsing-remitting or secondary progressive MS (diagnosed at least 3 months ago) - You have moderate to severe fatigue that significantly affects your daily life (FSMC score above 53) - Your MS medications have been stable for at least 3 months **You may NOT be eligible if:** - You are pregnant or may become pregnant during the study - You have had a MS relapse or steroid treatment in the last 3 months - You are already receiving a treatment specifically targeting fatigue - You have a major psychiatric disorder (like severe depression or psychosis) - You have a high disability score (EDSS above 6.5, meaning significant walking difficulties) - You have a history of epilepsy or metal implants in your head Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEReal Repetitive Transcranial Magnetic Stimulation

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 ).

DEVICESham Repetitive Transcranial Magnetic Stimulation

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 ).