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

This study has been completed.
Information provided by:
University Hospital, Clermont-Ferrand Identifier:
First received: October 17, 2005
Last updated: January 19, 2010
Last verified: January 2010
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00241566

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

Responsible Party: Pr Jean-Jacques LEMAIRE, CHU Clermont-Ferrand Identifier: NCT00241566     History of Changes
Other Study ID Numbers: CHU63-0002 
Study First Received: October 17, 2005
Last Updated: January 19, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Neuropathic pain
Electric cortical stimulation
Economic Medical evaluation

Additional relevant MeSH terms:
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms processed this record on May 02, 2016