Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclero
Neuromodulation of the Left Premotor Cortex With Transcranial Magnetic Stimulation to Alleviate Fatigue in Multiple Sclerosis - a Randomised Controlled Clinical Trial
What it found
No result yet.
What was tested
Treatment tested
- Real Repetitive Transcranial Magnetic Stimulation
Placebo
- Sham Repetitive Transcranial Magnetic Stimulation
What it measured
Main measures
Change from baseline in patient reported fatigue severity, measured by the Fatigue Scale for Motor and Cognitive Symptoms (FSMC) from baseline to +6 days
Follow-up at 6 days post intervention. Compared to baseline
Thinking and memoryFatigueQuality of life (reported by participants)
Other measures (5)
Change from baseline in regional brain tissue concentration of glutamate/glutamine in the stimulated premotor cortex, measured by single-voxel Magnetic Resonance Spectroscopy
Day 5 of intervention and 6 days post end of intervention, compared to baseline
MRI lesionsChange from baseline in Brain tissue concentration of GABA in the stimulated premotor cortex, measured by single-voxel Magnetic Resonance Spectroscopy
Day 5 of intervention and 6 days post end of intervention, compared to baseline
MRI lesionsChange from baseline in patient reported fatigue severity, measured by the Fatigue Scale for Motor and Cognitive Symptoms (FSMC)
Follow-up at 1 and 28 days post intervention. Compared to baseline.
Thinking and memoryFatigueQuality of life (reported by participants)Change from baseline in objective fatiguability, measured by the Fatiguability Index (FI)
Follow-up at 6 days post intervention. Compared to baseline.
FatigueChange from baseline in patient-reported fatiguability, measured by the Pittsburgh Fatiguability Score (PFS)
Follow-up at 1, 6 and 28 days post intervention. Compared to baseline.
Thinking and memoryFatigueQuality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
Papers
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History
Started
Aug 2024
Main results due
Jan 2027
Finished
Feb 2027