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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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial stimulation
Transcranial stimulation
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Sound placebo

Sound

Outcomes

Primary Outcome Measures

Analgesic efficiency

Secondary Outcome Measures

Additional evaluation of the pain
Evaluation of the quality of life
Evaluation of the tolerance of the treatment

Full Information

First Posted
June 9, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00697398
Brief Title
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Sound placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Sound
Intervention Type
Other
Intervention Name(s)
Transcranial stimulation
Intervention Description
Stimulation to white
Intervention Type
Other
Intervention Name(s)
Transcranial stimulation
Intervention Description
Repetitive transcranial magnetic stimulation (rTMS)
Primary Outcome Measure Information:
Title
Analgesic efficiency
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Additional evaluation of the pain
Time Frame
36 months
Title
Evaluation of the quality of life
Time Frame
36 months
Title
Evaluation of the tolerance of the treatment
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Guedj, MD
Organizational Affiliation
Assistance Publique des hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire
City
Marseille
ZIP/Postal Code
13385
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24670891
Citation
Boyer L, Dousset A, Roussel P, Dossetto N, Cammilleri S, Piano V, Khalfa S, Mundler O, Donnet A, Guedj E. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology. 2014 Apr 8;82(14):1231-8. doi: 10.1212/WNL.0000000000000280. Epub 2014 Mar 26.
Results Reference
derived

Learn more about this trial

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

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