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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Esquirol
Sponsor:
Information provided by (Responsible Party):
Jean-Christophe Dumont, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01942538
First received: September 11, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Fibromyalgia
Device: rTMS
Device: sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Esquirol:

Primary Outcome Measures:
  • number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months [ Time Frame: 210 days ] [ Designated as safety issue: No ]

    = 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:
  • number of rTMS responders at 3week-rTMS treatment [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: September 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS-rTMS
subjects receiving real rTMS treatment and real rTMS maintenance sessions
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
Sham Comparator: sham - sham
subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions
Device: sham rTMS
same session as defined with the real rTMS, but with a coil not delivering magnetic field.
Sham Comparator: rTMS-sham
subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment
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
real rTMS for 3 weeks but without clinical improvement
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
Sham Comparator: sham
sham treatment for 3 weeks without clinical improvement
Device: sham rTMS
same session as defined with the real rTMS, but with a coil not delivering magnetic field.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942538

Contacts
Contact: Jean-Christophe Dumont, MD 0033555056870 j.christophe.dumont@gmail.com
Contact: Murielle Girard, PhD 0033555431028 murielle.girard@ch-esquirol-limoges.fr

Locations
France
Centre Hospitalier Esquirol Recruiting
Limoges, France, 87000
Principal Investigator: Dominique Malauzat, MD         
Centre Hospitalier Universitaire Recruiting
Limoges, France, 87000
Sub-Investigator: Pascale Vergne-Salle, MD         
Principal Investigator: Philippe Bertin, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
Principal Investigator: Jean-Christophe Dumont, MD CHU Dupuytren CH Esquirol
  More Information

Publications:
Responsible Party: Jean-Christophe Dumont, Medical Doctor, Assistant in Rheumatologia Service CHU Limoges, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01942538     History of Changes
Other Study ID Numbers: 2013-A00820-45
Study First Received: September 11, 2013
Last Updated: May 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Esquirol:
rTMS
fibromyalgia
sham
maintenance session
pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014