MedTrace Logo

STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy

NCT00228371 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-05-28

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

Neurostimulation

High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Stephan CHABARDES, Dr · University Hospital of Grenoble, Neuro surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00228371 on ClinicalTrials.gov