Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients

Sponsor
Hospital Ambroise Paré Paris
Study ID
NCT07642882
Status
Recruiting
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Conditions

  • Chronic Pain
  • Depression - Major Depressive Disorder
  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • rTMS — DEVICE
    The active protocol will include 5 daily stimulation sessions during the first week (D1-D5), followed by one session per week for 3 weeks (W2, W3, W4), then 2 sessions spaced 2 weeks apart (W6, W8), for a total of 10 stimulation sessions. Evaluation will continue until 2 weeks after the final stimulation, that is, at week 10 after the start of treatment.
  • Sham — DEVICE
    The sham protocol will follow an identical session schedule. Participants will be randomized to either the active or sham group in a parallel-group design, meaning each participant will receive only one of the two treatments throughout the entire duration of the study.

Study Details

Repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex is a recognized analgesic technique for the treatment of fibromyalgia pain, which represents a largely unmet medical need. However, the effectiveness of motor cortex rTMS is inconsistent, being observed in only about 40% of patients and not always long-lasting. It has been previously shown that predictive factors for a lack of response to motor cortex rTMS include the presence of depressive symptoms, and that prefrontal cortex rTMS is not effective for pain, even though this treatment has proven efficacy in major depressive disorder. The hypothesis is that targeting both the motor and prefrontal cortices with rTMS will yield a particularly beneficial effect in fibromyalgia patients presenting with comorbid depressive symptoms. Given the absence of established biomarkers for predicting rTMS response, an additional aim will be to develop reliable indicators of rTMS efficacy, based on clinical phenotype and measurements of oscillatory patterns assessed by electroencephalogram (EEG) recordings.

Key Dates

First listed
Jun 11, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active rTMS of motor and prefrontal cortex
    Each rTMS session for each cortical target will include 30 trains of pulses delivered at 10 Hz for 10 seconds (100 pulses per train), with a 20-second interval between each train, resulting in a total of 3,000 pulses per session. The total duration will be 15 to 20 minutes per target, and 30 to 40 minutes for both cortical targets combined. The stimulation intensity for the left motor cortex will be set at 80% of the resting motor threshold, defined as the minimal stimulation intensity that induces an electromyographic response of ≥50 µV in the first dorsal interosseous muscle of the hand, contralateral to the stimulated hemisphere, in at least 5 out of 10 trials. For stimulation of the left prefrontal cortex, we will use a stimulation intensity of 120% of the motor threshold, as is customary in psychiatry and as in our previous studies on analgesia (Attal et al., 2021).
  • Sham Comparator: Sham rTMS of motor and prefrontal cortex
    To perform the rTMS, a figure-of-eight Cool-B65 A/P coil (MagVenture) will be used. This coil features a symmetrical design with two indistinguishable faces-one for active stimulation and the other for sham stimulation. The side used for each rTMS session will be determined by a personalized USB key for each patient, which will be connected to the rTMS device. The sound emitted during stimulation will be identical regardless of the side of the coil used. Finally, to further strengthen the treatment blinding for both the patient and the operator, the scalp-tapping sensation induced by active rTMS will be mimicked by low-intensity electrical stimulation applied to the head via surface electrodes. This electrical stimulation will be synchronized with the magnetic pulses during both active and sham stimulation sessions.

Primary Outcome Measure

Change in average pain intensity over 10 weeks (Brief Pain Inventory) [ Time Frame: From enrollment to Week 10. ]

Central Contacts

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