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

NCT ID: NCT01942538

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-07-28

Brief Summary

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

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

rTMS-rTMS

subjects receiving real rTMS treatment and real rTMS maintenance sessions

Group Type: EXPERIMENTAL

rTMS

Intervention Type: 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 - sham

subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions

Group Type: SHAM_COMPARATOR

sham rTMS

Intervention Type: DEVICE

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

rTMS-sham

subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment

Group Type: SHAM_COMPARATOR

rTMS

Intervention Type: 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

Intervention Type: DEVICE

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

rTMS

real rTMS for 3 weeks but without clinical improvement

Group Type: EXPERIMENTAL

rTMS

Intervention Type: 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

sham treatment for 3 weeks without clinical improvement

Group Type: SHAM_COMPARATOR

sham rTMS

Intervention Type: DEVICE

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

Interventions

rTMS

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

Intervention Type: DEVICE

sham rTMS

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Esquirol

OTHER

Sponsor Role: lead

Responsible Party

Jean-Christophe Dumont

Medical Doctor, Assistant in Rheumatologia Service CHU Limoges

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Christophe Dumont, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Dupuytren CH Esquirol

Locations

Centre Hospitalier Esquirol

Limoges, , France

Centre Hospitalier Universitaire

Limoges, , France

Countries

France

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.

Reference Type: BACKGROUND

PMID: 23673085 (View on PubMed)

Other Identifiers

2013-A00820-45

Identifier Type: -

Identifier Source: org_study_id