Investigating rTMS Effects on Fatigue in MS
A study was designed to evaluate the impact of real repetitive transcranial magnetic stimulation (rTMS) compared to sham treatment on fatigue in patients with relapsing-remitting multiple sclerosis (RRMS). Participants' fatigue severity will be measured before and 6 days after the intervention.
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Why it matters
If effective, rTMS could provide a new method to alleviate fatigue in MS patients, a common and debilitating symptom that significantly affects quality of life.
What this does not prove
No results have been posted yet; the findings are based solely on planned protocols, not actual data.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
Supporting passages (13)
study phaseThe trial consists of a baseline period; an intervention period; and a follow-up period.
study designThis is a one-site study, and will be monitored by an internal monitoring process, akin to Good Clinical Practice guidelines.
subjectsFor outcomes, see relevant section.\n\nSTUDY DESIGN:\n\nThe trial consists of a baseline period; an intervention period; and a follow-up period.\n\nAt the baseline visit (D0), all participants will undergo clinical testing; structural 7T MRI; 7T MR Spectroscopy (MRS) to acquire baseline neurometabolite concentrations; functional connectivity (rs-fMRI) and structural connectivity (DWI).
randomized"interventionModelDescription": "Randomized (1:1) parallel group study to either active treatment or sham",
controlledRepetitive transcranial magnetic stimulation to alleviate fatigue in multiple sclerosis-study protocol for a randomized sham-controlled double-blinded clinical trial.
regulatory approval"isFdaRegulatedDevice": false
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\n* A confirmed diagnosis of relapse-remitting or secondary progressive multiple sclerosis, according to most recent McDonald's criteria (Thompson et al., 2018).
intervention"Active Repetitive Transcranial Magnetic Stimulation (rTMS)"
comparatorRepetitive transcranial magnetic stimulation to alleviate fatigue in multiple sclerosis-study protocol for a randomized sham-controlled double-blinded clinical trial.
primary endpoint"measure": "Change from baseline in patient reported cognitive fatigue severity, measured by the Fatigue Scale for Motor and Cognitive Symptoms (FSMC), cognitive subscore",
follow upFollow-up at 6 days post intervention.
findings"briefSummary": "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.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
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