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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Jean-Christophe Dumont, Centre Hospitalier Esquirol.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01942538
First Posted: September 16, 2013
Last Update Posted: August 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean-Christophe Dumont, Centre Hospitalier Esquirol
September 11, 2013
September 16, 2013
August 6, 2015
September 2013
August 2016   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01942538 on ClinicalTrials.gov Archive Site
number of rTMS responders at 3week-rTMS treatment [ Time Frame: 21 days ]
Same as current
Not Provided
Not Provided
 
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia
Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • 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.
  • Experimental: rTMS-rTMS
    subjects receiving real rTMS treatment and real rTMS maintenance sessions
    Intervention: Device: rTMS
  • Sham Comparator: sham - sham
    subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions
    Intervention: Device: sham rTMS
  • Sham Comparator: rTMS-sham
    subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment
    Interventions:
    • Device: rTMS
    • Device: sham rTMS
  • Experimental: rTMS
    real rTMS for 3 weeks but without clinical improvement
    Intervention: Device: rTMS
  • Sham Comparator: sham
    sham treatment for 3 weeks without clinical improvement
    Intervention: Device: sham rTMS
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
78
February 2017
August 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01942538
2013-A00820-45
No
Not Provided
Not Provided
Jean-Christophe Dumont, Centre Hospitalier Esquirol
Centre Hospitalier Esquirol
Not Provided
Principal Investigator: Jean-Christophe Dumont, MD CHU Dupuytren CH Esquirol
Centre Hospitalier Esquirol
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP