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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942538
• Other study ID #: 2013-A00820-45
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: July 28, 2017

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Esquirol	Limoges
France	Centre Hospitalier Universitaire	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months	= 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.	210 days
Secondary	number of rTMS responders at 3week-rTMS treatment		21 days