Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
Recruiting · NCT06569550 · Interventional (participants receive a specific treatment) · Lead sponsor: Danish Research Centre for Magnetic Resonance
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed.
- Danish Research Centre for Magnetic Resonance - Hvidovre, Capital Region, Denmark