STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy

May 27, 2015 updated by: University Hospital, Grenoble

Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit. A Randomized, Double Blind, Controlled Trial.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 seizures. The existence of those circuits leads to the possibility of therapeutic applications in particular deep brain stimulation.

Preliminary results (Benabid et al, 2002) (Chabardes et al , 2002) suggest that the neuromodulation of basal ganglia and in particular the subthalamic nucleus and the substantia nigra pars reticulata could have a therapeutic effects in patients with drug resistant epilepsy and no possibility of resection surgery.

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.

Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.

There are two differents groups at phase 3 :

  • Group A : 10 patients with the stimulator switch ON for three months and switch OFF for the next three months.
  • Group B : 10 patients with the opposite sequence, OFF and ON.

Main objective :

- To show that high frequency deep brain stimulation of the subthalamic nucleus decrease the frequency of epileptic seizure compared with no stimulation.

Secondary objectives :

  • To show that high frequency deep brain stimulation of the subthalamic nucleus improve the quality of life.
  • To describe the side effects of this device and compare with those described in Parkinson patients. In particular to check the onset of dyskinesia related to dopamine.
  • To compare the distribution of seizure frequency after stimulation to the base line.
  • To show that the number of patients responding to treatment are higher in the group with stimulator switch ON than in the group with the stimulator turn OFF.
  • To compare the number of days without seizure with the stimulator switch ON or OFF.
  • To evaluated the neuropsychologic effect induced by the neurostimulation
  • To quantify the types and the ratio of different seizures during the ON phase and the OFF phase.
  • To monitor the secondary drug use during the study.

Control visits : all patients will have a control visit every 4 weeks during the study.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • University Hospital of Rennes
      • Strasbourg, France, 67091
        • University Hospital of Strasbourg
    • Isere
      • Grenoble, Isere, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
The stimulator is switch ON during the first phase of the cross-over and switch OFF during the second phase
Device: Neurostimulation
High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA
Other Names:
  • Neurostimulation of subthalamic nucleus
Other: 2
The stimulator is switch OFF during the first phase of the cross-over and switch ON during the second phase
Device: Neurostimulation
High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA
Other Names:
  • Neurostimulation of subthalamic nucleus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- Daily seizure frequency at each phase
Time Frame: at each phase
at each phase

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of days without seizure during each phase
Time Frame: at each phase
at each phase
Quality of life : SEALS, QOLIE-31 and NHP scales
Time Frame: at each phase
at each phase
Neuropsychological test : WAIS, GROBER and Busckhe, Wisconsin Card Sorting Test, TRAIL test, LURIA test, Beck Depression Inventory, verbal flow test, empathy test
Time Frame: at each phase
at each phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Stephan CHABARDES, Dr, University Hospital of Grenoble, Neuro surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 03 23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Neurostimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe