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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00697398
First received: June 9, 2008
Last updated: January 26, 2010
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

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

Primary Outcome Measures:
  • Analgesic efficiency [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional evaluation of the pain [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Evaluation of the quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Evaluation of the tolerance of the treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697398

Contacts
Contact: Eric Guedj, MD 49-138-5558 eric.guedj@ap-hm.fr
Contact: Philippe Roussel, MD 49-138-6998 philippe.roussel@ap-hm.fr

Locations
France
Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire Recruiting
Marseille, France, 13385
Contact: Eric GUEDJ, MD     49-138-5558        
Contact: Philippe ROUSSEL, MD     49-138-6898     philippe.roussel@ap-hm.fr    
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Eric Guedj, MD Assistance Publique des hopitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille, Assistance Publique des Hopitaux de Marseille
ClinicalTrials.gov Identifier: NCT00697398     History of Changes
Other Study ID Numbers: 2008-A00084-51, 2008-01
Study First Received: June 9, 2008
Last Updated: January 26, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013