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Clinical Trials/NCT00697398
NCT00697398
Completed
Not Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country38 target enrollmentOctober 2008
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
38
Locations
1
Primary Endpoint
Analgesic efficiency
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
October 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Analgesic efficiency

Time Frame: 36 months

Secondary Outcomes

  • Evaluation of the tolerance of the treatment(36 months)
  • Additional evaluation of the pain(36 months)
  • Evaluation of the quality of life(36 months)

Study Sites (1)

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