Status:
TERMINATED
STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Epilepsy
Drug Resistant
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to evaluate the effectiveness and the safety of deep brain stimulation in drug resistant epilepsy. This is a double blind, controlled and randomized clinical trial with two c...
Detailed Description
The experimental work performed for more than 15 years by several research teams shows in animal models of epilepsy, that several circuits of basal ganglia are involved in the control of epilepsy seiz...
Eligibility Criteria
Inclusion
- Epilepsy resistant to antiepileptic drug and dopaminergic D2 agonist.
- No curative exeresis surgery possible
- Metabolism deficiency of DOPA above 1 DS, evaluated by Positron Emission Tomography (PET) using fluorodopa
- Age ranging from 18 to 50
- capacity to consent
- Affiliation to the French Social Security
Exclusion
- pregnant woman or nursing mother
- change of antiepileptic, 30 days before base line
- convulsive "etat de mal" that requires an hospitalisation, 30 days before base line
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00228371
Start Date
September 1 2005
End Date
March 1 2010
Last Update
May 28 2015
Active Locations (3)
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1
University Hospital of Grenoble
Grenoble, Isere, France, 38043
2
University Hospital of Rennes
Rennes, France, 35000
3
University Hospital of Strasbourg
Strasbourg, France, 67091