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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00697398
First Posted: June 13, 2008
Last Update Posted: August 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  Purpose
Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

Condition Intervention
Fibromyalgia Other: Transcranial stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Analgesic efficiency [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Additional evaluation of the pain [ Time Frame: 36 months ]
  • Evaluation of the quality of life [ Time Frame: 36 months ]
  • Evaluation of the tolerance of the treatment [ Time Frame: 36 months ]

Enrollment: 38
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Sound placebo
Other: Transcranial stimulation
Stimulation to white
Experimental: 2
Sound
Other: Transcranial stimulation
Repetitive transcranial magnetic stimulation (rTMS)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697398


Locations
France
Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire
Marseille, France, 13385
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Eric Guedj, MD Assistance Publique des hopitaux de Marseille
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00697398     History of Changes
Other Study ID Numbers: 2008-A00084-51
2008-01
First Submitted: June 9, 2008
First Posted: June 13, 2008
Last Update Posted: August 28, 2014
Last Verified: January 2010

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases