Motor cortex repetitive transcranial magnetic stimulation in fibromyalgia: a multicentre randomised controlled trial.
Valquíria A Silva, Abrahão F Baptista, Alessandra S Fonseca...
https://pubmed.ncbi.nlm.nih.gov/40087077/Actively Recruiting
Led by Hospital Ambroise Paré Paris · Updated on 2026-06-11
36
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the analgesic effects of repetitive Transcranial Magnetic Stimulation rTMS targeting both the motor and prefrontal cortices in adults with fibromyalgia, particularly those with depressive symptoms. This trial aims to improve pain relief by combining stimulation sites, as motor cortex rTMS alone shows inconsistent results in about 40% of patients. Another goal is to develop reliable indicators of rTMS effectiveness using clinical features and brain activity measured by EEG. Participants will receive 10 rTMS sessions over about 2 months, starting with 5 daily sessions in the first week, followed by weekly sessions for 3 weeks, then two sessions spaced two weeks apart. Each session includes high-frequency stimulation to the motor and prefrontal cortices using a specialized coil, with treatment intensity adjusted based on individual motor thresholds. A sham group will receive identical session schedules with a placebo coil and synchronized electrical stimulation to mimic sensations. During the study, participants undergo brain MRI for coil positioning and complete questionnaires assessing pain, fatigue, sleep, mood, and quality of life at baseline, after the intensive treatment week, and two weeks post-treatment. Neurophysiological measures such as EEG and electromyography will also be recorded. The main outcome is change in average pain intensity over 10 weeks, with monitoring of secondary symptoms and safety throughout. Total participation lasts about 10 weeks from enrollment.
CONDITIONS
Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients
N
Nadine ATTAL
E
Elisa UMMARINO
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Hospital Ambroise Paré Paris
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 months
Participants receive 10 rTMS sessions over about 2 months, starting with 5 daily sessions in the first week, followed by weekly sessions for 3 weeks, then two sessions spaced two weeks apart. Each session involves stimulation of the motor and prefrontal cortices with a specialized coil.
10 sessions over 2 months
Duration - 2 weeks after treatment
Participants complete clinical and psychological questionnaires and neurophysiological tests at baseline, after the intensive treatment phase, and two weeks after treatment ends to assess changes in pain and other symptoms.
3 assessment visits
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/39816903/Hospital Ambroise Paré Paris
Lead Sponsor