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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 28, 2017

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.

Interventions

  • Device: rTMS
    • one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause – power equivalent to 90% of the motor threshold
  • Device: sham rTMS
    • same session as defined with the real rTMS, but with a coil not delivering magnetic field.

Arms, Groups and Cohorts

  • Experimental: rTMS-rTMS
    • subjects receiving real rTMS treatment and real rTMS maintenance sessions
  • Sham Comparator: sham – sham
    • subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions
  • Sham Comparator: rTMS-sham
    • subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment
  • Experimental: rTMS
    • real rTMS for 3 weeks but without clinical improvement
  • Sham Comparator: sham
    • sham treatment for 3 weeks without clinical improvement

Clinical Trial Outcome Measures

Primary Measures

  • number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
    • Time Frame: 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 Measures

  • number of rTMS responders at 3week-rTMS treatment
    • Time Frame: 21 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Esquirol
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jean-Christophe Dumont, Medical Doctor, Assistant in Rheumatologia Service CHU Limoges – Centre Hospitalier Esquirol
  • Overall Official(s)
    • Jean-Christophe Dumont, MD, Principal Investigator, CHU Dupuytren CH Esquirol

References

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.

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