Clinical trial NCT01942538: Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia
Official title: Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: rTMS
fibromyalgia
sham
maintenance session
pain
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
timeFrame: 210 days
Secondary outcomes:
measure: number of rTMS responders at 3week-rTMS treatment
timeFrame: 21 days
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Limoges
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU Dupuytren CH Esquirol
name: Jean-Christophe Dumont, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciobanu C, Girard M, Marin B, Labrunie A, Malauzat D. rTMS for pharmacoresistant major depression in the clinical setting of a psychiatric hospital: effectiveness and effects of age. J Affect Disord. 2013 Sep 5;150(2):677-81. doi: 10.1016/j.jad.2013.03.024. Epub 2013 May 11.