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Completed

NCT Number: NCT01942538

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Esquirol, Limoges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS

Device

one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold

sham rTMS

Device

same session as defined with the real rTMS, but with a coil not delivering magnetic field.

Primary outcomes

  1. 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 outcomes

  1. number of rTMS responders at 3week-rTMS treatment

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Esquirol

Other

Registry information

Official study title

Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2013
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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