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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• A confirmed diagnosis of relapse-remitting 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

Locations
Other Locations
Denmark
Danish Research Centre for Magnetic Resonance
RECRUITING
Hvidovre
Contact Information
Primary
Hartwig R Siebner, MD, DMSc
hartwig@drcmr.dk
3862 6541
Backup
Sofus AD Nygaard, MD
sofusadn@drcmr.dk
Time Frame
Start Date: 2024-08-14
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 60
Treatments
Active_comparator: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham_comparator: Sham Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Related Therapeutic Areas
Sponsors
Collaborators: Independent Research Fund Denmark, Danish Multiple Sclerosis Center, Scleroseforeningen
Leads: Danish Research Centre for Magnetic Resonance

This content was sourced from clinicaltrials.gov