Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228371
Status:
TERMINATED
Last Update Posted:
2015-05-28
First Post:
2005-09-26
Brief Title:
STIMEP Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit A Randomized Double Blind Controlled Trial
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficent enrolement
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None