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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241566
First Posted: October 19, 2005
Last Update Posted: January 20, 2010
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.
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose
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 Intervention Phase
Neuropathic Pain Rebel Device: implantation of stimulator Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Cost of treatment of this pathology

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

Estimated Enrollment: 200
Study Start Date: August 2003
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

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 Submitted: October 17, 2005
First Posted: October 19, 2005
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