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

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ClinicalTrials.gov Identifier: NCT00241566
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:

Study Description
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

Study Design

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
Primary Completion Date : August 2007
Study Completion Date : December 2007
Arms and Interventions


Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00241566


Locations
France
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
Investigators
Principal Investigator: Jean-Jacques Lemaire Clermont-Ferrand UH
More Information

Responsible Party: Pr Jean-Jacques LEMAIRE, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00241566     History of Changes
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:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms