Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia

Study Overview
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Brief Summary
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Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.

Detailed Description
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In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.

Official Title
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Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: rTMS
* Device: sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis, painful state for more than six months, visual analogic scale evaluation > or = 5, age between 18 and 70, no modification in therapeutic treatment one month before and during the protocol presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic residence in Limoges or the periphery, or the ability to come to the hospital for the treatment Exclusion Criteria: presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble), active epilepsy, previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension, pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging. clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...), pregnancy, or administrative and judiciary protection, absence of health insurance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS-rTMS<br>subjects receiving real rTMS treatment and real rTMS maintenance sessions | Device: rTMS<br>* one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold<br>|
| Sham Comparator: sham - sham<br>subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions | Device: sham rTMS<br>* same session as defined with the real rTMS, but with a coil not delivering magnetic field.<br>|
| Sham Comparator: rTMS-sham<br>subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment | Device: rTMS<br>* one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold<br>Device: sham rTMS<br>* same session as defined with the real rTMS, but with a coil not delivering magnetic field.<br>|
| Experimental: rTMS<br>real rTMS for 3 weeks but without clinical improvement | Device: rTMS<br>* one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold<br>|
| Sham Comparator: sham<br>sham treatment for 3 weeks without clinical improvement | Device: sham rTMS<br>* same session as defined with the real rTMS, but with a coil not delivering magnetic field.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months | = number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions. clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change. effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions. | 210 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of rTMS responders at 3week-rTMS treatment |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, fibromyalgia, sham, maintenance session, pain