Back to resultsEconomic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
Primary Purpose
Neuropathic Pain Rebel
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
implantation of stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain Rebel focused on measuring Neuropathic pain, Electric cortical stimulation, Economic Medical evaluation
Eligibility 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
Sites / Locations
- Clermont-Ferrand UH
- Neurosurgery - Henri Mondor Hospital
Outcomes
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.
Full Information
NCT ID
NCT00241566
First Posted
October 17, 2005
Last Updated
January 19, 2010
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT00241566
Brief Title
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
Official Title
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain Rebel
Keywords
Neuropathic pain, Electric cortical stimulation, Economic Medical evaluation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
implantation of stimulator
Primary Outcome Measure Information:
Title
Cost of treatment of this pathology
Secondary Outcome Measure Information:
Title
Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Lemaire
Organizational Affiliation
Clermont-Ferrand UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clermont-Ferrand UH
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Facility Name
Neurosurgery - Henri Mondor Hospital
City
Créteil
State/Province
Ile de France
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation
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