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Completed

NCT Number: NCT00697398

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Marseille, 13385, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial stimulation

Other

Stimulation to white

Primary outcomes

  1. Analgesic efficiency

    Time frame: 36 months

Secondary outcomes

  1. Additional evaluation of the pain

    Time frame: 36 months

  2. Evaluation of the quality of life

    Time frame: 36 months

  3. Evaluation of the tolerance of the treatment

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2008
Registry last updated
Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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