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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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Transcranial stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00697398
2008-A00084-51
2008-01

Details and patient eligibility

About

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

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups, including a placebo group

1
Placebo Comparator group
Description:
Sound placebo
Treatment:
Other: Transcranial stimulation
Other: Transcranial stimulation
2
Experimental group
Description:
Sound
Treatment:
Other: Transcranial stimulation
Other: Transcranial stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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