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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697398
• Other study ID #: 2008-A00084-51
• Secondary ID: 2008-01
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: August 27, 2014
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: January 2010
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Transcranial stimulation
Stimulation to white
• Transcranial stimulation
Repetitive transcranial magnetic stimulation (rTMS)

Locations

Country	Name	City	State
France	Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic efficiency		36 months	No
Secondary	Additional evaluation of the pain		36 months	No
Secondary	Evaluation of the quality of life		36 months	No
Secondary	Evaluation of the tolerance of the treatment		36 months	No