Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Research Centre for Magnetic Resonance

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Real Repetitive Transcranial Magnetic Stimulation
  • Sham Repetitive Transcranial Magnetic Stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Danish Research Centre for Magnetic Resonance

Lead sponsor

Danish Multiple Sclerosis Center

Collaborator

Scleroseforeningen

Collaborator

Independent Research Fund Denmark

Collaborator