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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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 :
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 :
Control visits : all patients will have a control visit every 4 weeks during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | The stimulator is switch ON during the first phase of the cross-over and switch OFF during the second phase |
|
| 2 | Other | The stimulator is switch OFF during the first phase of the cross-over and switch ON during the second phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulation | Device | High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA |
|
| Measure | Description | Time Frame |
|---|---|---|
| - Daily seizure frequency at each phase | at each phase |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days without seizure during each phase | at each phase | |
| Quality of life : SEALS, QOLIE-31 and NHP scales | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan CHABARDES, Dr | University Hospital of Grenoble, Neuro surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble | Grenoble | Isere | 38043 | France | ||
| University Hospital of Rennes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1695401 | Background | Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l. | |
| 10443887 | Background | Ardouin C, Pillon B, Peiffer E, Bejjani P, Limousin P, Damier P, Arnulf I, Benabid AL, Agid Y, Pollak P. Bilateral subthalamic or pallidal stimulation for Parkinson's disease affects neither memory nor executive functions: a consecutive series of 62 patients. Ann Neurol. 1999 Aug;46(2):217-23. doi: 10.1002/1531-8249(199908)46:23.0.co;2-z. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| at each phase |
| Rennes |
| 35000 |
| France |
| University Hospital of Strasbourg | Strasbourg | 67091 | France |
| 11697687 | Background | Benabid AL, Koudsie A, Benazzouz A, Vercueil L, Fraix V, Chabardes S, Lebas JF, Pollak P. Deep brain stimulation of the corpus luysi (subthalamic nucleus) and other targets in Parkinson's disease. Extension to new indications such as dystonia and epilepsy. J Neurol. 2001 Sep;248 Suppl 3:III37-47. doi: 10.1007/pl00007825. |
| 12015863 | Background | Benabid AL, Minotti L, Koudsie A, de Saint Martin A, Hirsch E. Antiepileptic effect of high-frequency stimulation of the subthalamic nucleus (corpus luysi) in a case of medically intractable epilepsy caused by focal dysplasia: a 30-month follow-up: technical case report. Neurosurgery. 2002 Jun;50(6):1385-91; discussion 1391-2. doi: 10.1097/00006123-200206000-00037. |
| 12495878 | Background | Chabardes S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93. |
| 9711758 | Background | Chkhenkeli SA, Chkhenkeli IS. Effects of therapeutic stimulation of nucleus caudatus on epileptic electrical activity of brain in patients with intractable epilepsy. Stereotact Funct Neurosurg. 1997;69(1-4 Pt 2):221-4. doi: 10.1159/000099878. |
| 4206369 | Background | Cooper IS, Amin I, Gilman S. The effect of chronic cerebellar stimulation upon epilepsy in man. Trans Am Neurol Assoc. 1973;98:192-6. No abstract available. |
| 1695404 | Background | DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v. |
| 14684352 | Background | Dematteis M, Kahane P, Vercueil L, Depaulis A. MRI evidence for the involvement of basal ganglia in epileptic seizures: an hypothesis. Epileptic Disord. 2003 Sep;5(3):161-4. |