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

Centre Hospitalier Esquirol

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: sham rTMS; Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01942538

2013-A00820-45

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 5 patient groups

rTMS-rTMS

Experimental group

Description:

subjects receiving real rTMS treatment and real rTMS maintenance sessions

Treatment:

Device: rTMS

sham - sham

Sham Comparator group

Description:

subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions

Treatment:

Device: sham rTMS

rTMS-sham

Sham Comparator group

Description:

subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment

Treatment:

Device: sham rTMS

Device: rTMS

rTMS

Experimental group

Description:

real rTMS for 3 weeks but without clinical improvement

Treatment:

Device: rTMS

sham

Sham Comparator group

Description:

sham treatment for 3 weeks without clinical improvement

Treatment:

Device: sham rTMS