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Trial Title:
Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement
NCT ID:
NCT06241924
Condition:
Parkinson Disease
Epilepsy
Conditions: Official terms:
Ganglion Cysts
Parkinson Disease
Conditions: Keywords:
Focal seizure
Parkinson disease
Hyperkinetic seizures
Hypokinetic disorders
Dyskinesia
Networks
Basal ganglia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
High Resolution Electroencephalogram (EEG-HR)
Description:
Local field potentials (LFP) recording using EEG-HR
Arm group label:
parkinson disease
Intervention type:
Procedure
Intervention name:
Stereo-electro-encephalography (SEEG)
Description:
Local field potentials (LFP) recording using sEEG
Arm group label:
Epilepsy
Summary:
The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by
pathological synchronous oscillations of neuronal activity in this cortico-subcortical
network with a wide frequency range.
The purpose of this research is to study cortico-subcortical oscillations and their
synchronization in two pathologies emblematic of hypokinetic (Parkinson's disease) and
hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different
situations.
Detailed description:
In order to define the link between the characteristics of the oscillations (frequency,
amplitude, phase relation) within this cortico-subcortical network and movement (normal
or pathological) in humans, a simple motor task of gripping/pulling a lever has been
designed.
The local field potentials (LFPs) will be collected during the same motor task in :
i) patients with Parkinson's disease, using a high-resolution electroencephalogram (EEG)
and the PERCEPT(TM) system (Medtronic) equipped with a "sensing" function for deep LFP
recordings and in EEG-HR (for high resolution) for cortical recordings
ii) patients with focal drug-resistant epilepsy, during a pre-surgical assessment by
stereo-electro-encephalography (SEEG). The SEEG allows the recording of both the cortex
and the subcortical regions in a concomitant manner, and a direct correlation can be
studied.
Criteria for eligibility:
Criteria:
Inclusion criteria :
- Male or Female
- Between 18 and 75 years of age
- With Parkinson's disease and already operated with implantation of electrodes in the
Subthalamic nucleus connected to a PERCEPT (TM) device.
- Giving free, informed, written consent signed by the participant and the
investigator Or
- With drug-resistant epilepsy and benefiting from a phase II pre-surgical assessment
with intracerebral electrophysiological exploration by stereo-EEG
- With at least one electrode exploring the basal ganglia or the thalamus.
- Able to perform the simple motor task
- Affiliated or beneficiary of a social security scheme;
- Giving free, informed, written consent signed by the participant and the
investigator
Exclusion criteria:
- Be incapable of giving consent personally
- Be subject to a legal protection measure or be placed under judicial protection;
- Being pregnant or breastfeeding
- Present a serious and/or decompensated somatic or psychiatric illness
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Bordeaux
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Last name:
Jérôme Aupy
Phone:
05 56 71 43 33
Contact backup:
Last name:
Olivier Branchard
Phone:
05 57 82 06 97
Email:
olivier.branchard@chu-bordeaux.fr
Start date:
February 5, 2024
Completion date:
February 5, 2027
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06241924
