STIMEP : Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy
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| ClinicalTrials.gov Identifier: NCT00228371 |
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Recruitment Status :
Terminated
(insufficent enrolement)
First Posted : September 28, 2005
Last Update Posted : May 28, 2015
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy Drug Resistant | Device: Neurostimulation | Phase 2 Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, 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. |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | March 2010 |
| Arm | Intervention/treatment |
|---|---|
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1
The stimulator is switch ON during the first phase of the cross-over and switch OFF during the second phase
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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 |
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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 |
- - Daily seizure frequency at each phase [ Time Frame: at each phase ]
- The number of days without seizure during each phase [ Time Frame: at each phase ]
- Quality of life : SEALS, QOLIE-31 and NHP scales [ Time Frame: 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 ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228371
| France | |
| University Hospital of Grenoble | |
| Grenoble, Isere, France, 38043 | |
| University Hospital of Rennes | |
| Rennes, France, 35000 | |
| University Hospital of Strasbourg | |
| Strasbourg, France, 67091 | |
| Principal Investigator: | Stephan CHABARDES, Dr | University Hospital of Grenoble, Neuro surgery |
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00228371 |
| Other Study ID Numbers: |
DCIC 03 23 |
| First Posted: | September 28, 2005 Key Record Dates |
| Last Update Posted: | May 28, 2015 |
| Last Verified: | May 2015 |
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Epilepsy deep brain stimulation Subthalamic nucleus Drug resistant epilepsy |
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Epilepsy Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |