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Efficacy of Cortex Stimulation in Neuropathic Pain
This study has been terminated.
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00224666
  Purpose

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 .


Condition Intervention Phase
Rebel Neuropathic Pains
Device: Cortex stimulation
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Estimated Enrollment: 16
Study Start Date: March 2001
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neurofibromatosis,
  • Rebel chronic neuropathic pain with duration > 1 year and AVS > = 4

Exclusion Criteria:

  • Cancer
  • Epilepsy
  • Cognitive deterioration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224666

Locations
France
Hopital Henri Mondor
CRETEIL, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: N'GUYEN, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Study ID Numbers: P000901, AOM98134
Study First Received: September 16, 2005
Last Updated: January 9, 2007
ClinicalTrials.gov Identifier: NCT00224666  
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cortex stimulation ,Rebel neuropathic pains

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on January 16, 2009