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STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy

University Hospital, Grenoble · 2005
ClinicalTrials.gov · Datasets · License: Public Domain · 2005
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deep-brain-stimulationepilepsysubthalamic-nucleus
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 cross-over groups and four phases. Phase 1 : base line, open phase consisting of follow-up of patients with their standard treatment. Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the stimulator switch OFF. Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF depending on randomization allocation, followed by 3 months with the stimulator switch on the opposite position. The placebo consisting of turn OFF the stimulator. Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.
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