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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Sound placebo

Group Type PLACEBO_COMPARATOR

Transcranial stimulation

Intervention Type OTHER

Stimulation to white

2

Sound

Group Type EXPERIMENTAL

Transcranial stimulation

Intervention Type OTHER

Repetitive transcranial magnetic stimulation (rTMS)

Interventions

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Transcranial stimulation

Stimulation to white

Intervention Type OTHER

Transcranial stimulation

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No