Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Device: rTMSDevice: sham rTMS
- Registration Number
- NCT01942538
- Lead Sponsor
- Centre Hospitalier Esquirol
- Brief Summary
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rTMS rTMS real rTMS for 3 weeks but without clinical improvement rTMS-sham rTMS subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment rTMS-rTMS rTMS subjects receiving real rTMS treatment and real rTMS maintenance sessions rTMS-sham sham rTMS subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment sham - sham sham rTMS subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions sham sham rTMS sham treatment for 3 weeks without clinical improvement
- Primary Outcome Measures
Name Time Method number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months 210 days = 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.
- Secondary Outcome Measures
Name Time Method number of rTMS responders at 3week-rTMS treatment 21 days
Trial Locations
- Locations (2)
Centre Hospitalier Esquirol
🇫🇷Limoges, France
Centre Hospitalier Universitaire
🇫🇷Limoges, France