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Efficacy of Cortex Stimulation in Neuropathic Pain

Primary Purpose

Rebel Neuropathic Pains

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cortex stimulation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rebel Neuropathic Pains focused on measuring Cortex stimulation ,Rebel neuropathic pains

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Neurofibromatosis, Rebel chronic neuropathic pain with duration > 1 year and AVS > = 4 Exclusion Criteria: Cancer Epilepsy Cognitive deterioration

Sites / Locations

  • Hopital Henri Mondor

Outcomes

Primary Outcome Measures

Efficacy of 50% of EVS at 3 weeks

Secondary Outcome Measures

Efficacy of 50% of EVS at 6 months and 12 months

Full Information

First Posted
September 16, 2005
Last Updated
January 9, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00224666
Brief Title
Efficacy of Cortex Stimulation in Neuropathic Pain
Official Title
Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

5. Study Description

Brief Summary
The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed. Principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .
Detailed Description
The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rebel Neuropathic Pains
Keywords
Cortex stimulation ,Rebel neuropathic pains

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cortex stimulation
Primary Outcome Measure Information:
Title
Efficacy of 50% of EVS at 3 weeks
Secondary Outcome Measure Information:
Title
Efficacy of 50% of EVS at 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neurofibromatosis, Rebel chronic neuropathic pain with duration > 1 year and AVS > = 4 Exclusion Criteria: Cancer Epilepsy Cognitive deterioration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
N'GUYEN, Pr,MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15572109
Citation
Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dolle F, Conde F, Bottlaender M, Peschanski M, Keravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78. doi: 10.1016/j.neuron.2004.11.023.
Results Reference
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PubMed Identifier
15026508
Citation
Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, Keravel Y, Nguyen JP. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):612-6. doi: 10.1136/jnnp.2003.022236.
Results Reference
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Efficacy of Cortex Stimulation in Neuropathic Pain

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