Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
- Last Updated
- 7 years ago
Overview
Brief Summary
Primary objective
Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.
Research hypotheses
The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.
Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :
- To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
- To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
- Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathology requiring brain stimulation therapy (criteria of severity, therapeutic resistance and severity of disability): motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders (eg OCD, depression).
- •These pathologies therefore include motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders that can be treated with brain stimulation therapy. Note that these are independent of motor disorders. The inclusion criteria obviously depend on the pathology.
- •As an example for a motor pathology treated by stimulation, in Parkinson's disease the following inclusion criteria are used :
- •patients aged 18 to 75 and affiliated to a social security scheme
- •Idiopathic Parkinson's disease that meets the United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria or suffering from recessive autosomal juvenile parkinsonism
- •duration of evolution of the disease\> 5 years
- •stage of severe motor complications of levodopa despite optimal treatment.
- •For dystonic patients, the following inclusion criteria are used :
- •Disabling dystonia (severe focal, segmental or generalized).
- •Patient ≥ 18 years of age and under age 65
Exclusion Criteria
- •Persons referred to in Articles L1121-5 to L1121-8 of the CSP.
Outcomes
Primary Outcomes
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
Time Frame: 5 days
The amplitude of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
Secondary Outcomes
- cognitive and sensorimotor tasks(5 days)
- functional atlas of basal ganglia(5 days)
- number of electrophysiological responses(5 days)