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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00241566
Other study ID # CHU63-0002
Secondary ID
Status Completed
Phase Phase 4
First received October 17, 2005
Last updated January 19, 2010
Start date August 2003
Est. completion date December 2007

Study information

Verified date January 2010
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
implantation of stimulator


Locations

Country Name City State
France Clermont-Ferrand UH Clermont-Ferrand Auvergne
France Neurosurgery - Henri Mondor Hospital Créteil Ile de France

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cost of treatment of this pathology
Secondary Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale.