NCT06569550Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 14 Aug 2024
- Primary completion date
- 21 Jan 2027
- Lead sponsor
- Danish Research Centre for Magnetic Resonance
- Diseases
- Multiple sclerosis
- NCT number
- NCT06569550
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 14 Aug 2024 to the primary completion date, 21 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Intake of medication that primarily acts on CNS or neurotransmission, except SSRI or SNRI
- Any metallic implant incompatible with MR scanning
- Current Drug or alcohol abuse
Other illness
- History of neurologic disease or other significant medical conditions, aside from MS
- Major psychiatric disorder, including current clinical depression.
- Either patient or their close relatives suffering from epilepsy
Other
- Pregnancy, any subject with the potential to become pregnant must ensure against this (e.g. by taking oral contraceptives, or other high efficacy method)
- EDSS \> 6.5
- Pacemaker or other implanted electronic devices
- Any intracranial metal
- Claustrophobia
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danish Research Centre for Magnetic Resonance Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.