Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

Parkinson Disease Clinical Trial

— BAG-OSMOV  

Official title:

Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241924
• Other study ID #: CHUBX 2022/80
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: February 5, 2027

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: Jérôme AUPY, Docteur
• Phone: 05 56 71 43 33
• Email: jerome.aupy[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 5, 2027
• Est. primary completion date: February 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Ganglion Cysts
• Parkinson Disease

Intervention

Procedure:
• High Resolution Electroencephalogram (EEG-HR)
Local field potentials (LFP) recording using EEG-HR
• Stereo-electro-encephalography (SEEG)
Local field potentials (LFP) recording using sEEG

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in the cortico-subcortical electrophysiological coherence value	difference in the cortico-subcortical electrophysiological coherence value between normal movement (control condition) and hypo- or hyperkinetic pathological movement	Day 1