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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00241566
First received: October 17, 2005
Last updated: January 19, 2010
Last verified: January 2010
  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
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

ClinicalTrials.gov processed this record on November 24, 2014