Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06241924
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Bordeaux
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jérôme AUPY, Docteur
Principal Investigator Affiliation University Hospital, Bordeaux
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Parkinson Disease, Epilepsy
Additional Details

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.

Arms & Interventions

Arms

Experimental: Epilepsy

Experimental: parkinson disease

Interventions

Procedure: - High Resolution Electroencephalogram (EEG-HR)

Local field potentials (LFP) recording using EEG-HR

Procedure: - Stereo-electro-encephalography (SEEG)

Local field potentials (LFP) recording using sEEG

Contact a Trial Team

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International Sites

CHU de Bordeaux, Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux

Bordeaux, , 33076

Site Contact

Jérôme Aupy

[email protected]

05 56 71 43 33

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