STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy

This study has been terminated.
(insufficent enrolement)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00228371
First received: September 26, 2005
Last updated: March 12, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug Resistant
Device: Neurostimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit. A Randomized, Double Blind, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • - Daily seizure frequency at each phase [ Time Frame: at each phase ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of days without seizure during each phase [ Time Frame: at each phase ] [ Designated as safety issue: Yes ]
  • Quality of life : SEALS, QOLIE-31 and NHP scales [ Time Frame: at each phase ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: September 2005
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Neurostimulation of subthalamic nucleus
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 Name: Neurostimulation of subthalamic nucleus

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228371

Locations
France
University Hospital of Grenoble
Grenoble, Isere, France, 38043
University Hospital of Rennes
Rennes, France, 35000
University Hospital of Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Grenoble
Ministry of Health, France
Investigators
Principal Investigator: Stephan CHABARDES, Dr University Hospital of Grenoble, Neuro surgery
  More Information

Publications:

Responsible Party: Dr Stephan Chabardes, Neurologic department of the grenoble university hospital
ClinicalTrials.gov Identifier: NCT00228371     History of Changes
Other Study ID Numbers: DCIC 03 23
Study First Received: September 26, 2005
Last Updated: March 12, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Epilepsy
deep brain stimulation
Subthalamic nucleus
Drug resistant epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014