Using magnetic stimulation to reduce fatigue in multiple sclerosis
Neuromodulation of the Left Premotor Cortex With Transcranial Magnetic Stimulation to Alleviate Fatigue in Multiple Sclerosis - a Randomised Controlled Clinical Trial
NA · Danish Research Centre for Magnetic Resonance · NCT06569550
This study is testing if a type of magnetic stimulation can help reduce fatigue in people with Relapsing-Remitting Multiple Sclerosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Danish Research Centre for Magnetic Resonance (other) |
| Locations | 1 site (Hvidovre, Capital Region) |
| Trial ID | NCT06569550 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if repetitive Transcranial Magnetic Stimulation (rTMS) of the left premotor cortex can alleviate fatigue in patients with Relapsing-Remitting Multiple Sclerosis. Participants will receive either real or sham rTMS for 30 minutes over five consecutive days, followed by assessments through questionnaires and brain scans to evaluate changes in fatigue levels and brain activity. The study seeks to understand the relationship between brain excitation and inhibition in relation to fatigue symptoms in these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Relapsing-Remitting Multiple Sclerosis who experience moderate to severe fatigue.
Not a fit: Patients with significant psychiatric disorders, recent MS relapses, or those currently receiving treatment for fatigue may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new non-pharmacological treatment option for managing fatigue in patients with Multiple Sclerosis.
How similar studies have performed: While the approach of using rTMS for fatigue in MS is relatively novel, similar studies have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hvidovre, Capital Region
- Danish Research Centre for Magnetic Resonance — Hvidovre, Capital Region, Denmark (RECRUITING)
Study contacts
- Principal investigator: Hartwig R Siebner, MD, DMSc — Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre & University of Copenhagen
- Study coordinator: Hartwig R Siebner, MD, DMSc
- Email: hartwig@drcmr.dk
- Phone: 3862 6541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Relapsing-Remitting, Fatigue, Transcranial Magnetic Stimulation, Repetitive, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Spectroscopy