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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT00697398
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Other: Transcranial stimulation; Other: Transcranial stimulation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• 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
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Sound placebo	Other: Transcranial stimulation; Stimulation to white
Experimental: 2 Sound	Other: Transcranial stimulation; Repetitive transcranial magnetic stimulation (rTMS)

Outcome Measures

Primary Outcome Measures

1. Analgesic efficiency [36 months]

Secondary Outcome Measures

1. Additional evaluation of the pain [36 months]

2. Evaluation of the quality of life [36 months]

3. Evaluation of the tolerance of the treatment [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT00697398
• Other Study ID Numbers: 2008-A00084-51; 2008-01
• First Posted: Jun 13, 2008
• Last Update Posted: Aug 28, 2014
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes

Study Results

No Results Posted as of Aug 28, 2014