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

C

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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