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Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241566
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : January 20, 2010
Information provided by:
University Hospital, Clermont-Ferrand

Brief Summary:
All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Rebel Device: implantation of stimulator Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
Study Start Date : August 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. Cost of treatment of this pathology

Secondary Outcome Measures :
  1. Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presence of pain caused by lesion of central or peripheral nervous system
  • Pain persistent since one year at least
  • Pain untreated with 3 different antalgic treatments

Exclusion Criteria

  • Pain linked t a malignant affection
  • patient < 18 years-old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00241566

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Clermont-Ferrand UH
Clermont-Ferrand, Auvergne, France, 63003
Neurosurgery - Henri Mondor Hospital
Créteil, Ile de France, France, 94010
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Principal Investigator: Jean-Jacques Lemaire Clermont-Ferrand UH

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Responsible Party: Pr Jean-Jacques LEMAIRE, CHU Clermont-Ferrand Identifier: NCT00241566    
Other Study ID Numbers: CHU63-0002
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010
Keywords provided by University Hospital, Clermont-Ferrand:
Neuropathic pain
Electric cortical stimulation
Economic Medical evaluation
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms