NCT06569550 Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
| NCT ID | NCT06569550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Research Centre for Magnetic Resonance |
| Condition | Multiple Sclerosis, Relapsing-Remitting |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-08-14 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Hartwig R Siebner, MD, DMSc
PRINCIPAL INVESTIGATOR
Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre & University of Copenhagen
Frequently Asked Questions
Who can join the NCT06569550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis, Relapsing-Remitting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06569550 currently recruiting?
Yes, NCT06569550 is actively recruiting participants. Contact the research team at hartwig@drcmr.dk for enrollment information.
Where is the NCT06569550 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT06569550 clinical trial?
NCT06569550 is sponsored by Danish Research Centre for Magnetic Resonance. The principal investigator is Hartwig R Siebner, MD, DMSc at Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre & University of Copenhagen. The trial plans to enroll 60 participants.
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