Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 14, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

February 1, 2026

Conditions
Multiple Sclerosis, Relapsing-RemittingFatigue
Interventions
DEVICE

Real 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 )."

DEVICE

Sham 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 )."

Trial Locations (1)

2650

RECRUITING

Danish Research Centre for Magnetic Resonance, Hvidovre

All Listed Sponsors
collaborator

Danish Multiple Sclerosis Center

UNKNOWN

collaborator

Scleroseforeningen

UNKNOWN

collaborator

Independent Research Fund Denmark

INDUSTRY

lead

Danish Research Centre for Magnetic Resonance

OTHER