Epilepsy Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04595513 -
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
|
Phase 1/Phase 2 | |
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05552924 -
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
|
N/A | |
Terminated |
NCT01668654 -
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
|
Phase 3 | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT03994718 -
Creative Arts II Study
|
N/A | |
Recruiting |
NCT04076449 -
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
|
||
Completed |
NCT00782249 -
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
Active, not recruiting |
NCT06034353 -
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
|
N/A | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
Not yet recruiting |
NCT05559060 -
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
|
||
Completed |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
Completed |
NCT02646631 -
Behavioral and Educational Tools to Improve Epilepsy Care
|
N/A | |
Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
Recruiting |
NCT02539134 -
TAK-935 Multiple Rising Dose Study in Healthy Participants
|
Phase 1 | |
Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A | |
Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A |