Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Transcranial stimulation

• Registration Number: NCT00697398
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

Detailed Description

We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.

Study Timeline

• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Study Start: 2008-10
• Status Verified: 2010-01
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Female or male patient, aged from 18 to 65 years
• Patient presenting a primary fibromyalgia answering the criteria of the ACR
• At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
• Patient presenting a stable treatment since at least 1 less

Exclusion Criteria

• Patient minor
• pregnant woman
• women in age to procreate without contraception
• patient deprived of freedom further to a court or administrative order
• patient presenting a secondary fibromyalgia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Transcranial stimulation	Sound
1	Transcranial stimulation	Sound placebo

Primary Outcome Measures

Name	Time	Method
Analgesic efficiency	36 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of the tolerance of the treatment	36 months
Additional evaluation of the pain	36 months
Evaluation of the quality of life	36 months

Trial Locations

Locations (1)

Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire; 🇫🇷 Marseille, France