Oscillatory Activity in Basal Ganglia Circuits During Nor... | NCT06241924

Studies
Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

NCT06241924

Sponsor

University Hospital, Bordeaux

Status

Recruiting

Last Update Posted

Jul 23, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Parkinson Disease
Epilepsy

Interventions

High Resolution Electroencephalogram (EEG-HR)
Stereo-electro-encephalography (SEEG)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2024Actual

Primary Completion Date

Feb 5, 2027Estimated

Completion Date

Feb 5, 2027Estimated

First Submitted Date

Jan 26, 2024

First Submission Date that Met QC Criteria

Jan 26, 2024

First Posted Date

Feb 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2025

Last Update Posted Date

Jul 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epilepsy	Experimental		Procedure: Stereo-electro-encephalography (SEEG)
parkinson disease	Experimental		Procedure: High Resolution Electroencephalogram (EEG-HR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Resolution Electroencephalogram (EEG-HR)	Procedure	Local field potentials (LFP) recording using EEG-HR	parkinson disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jérôme AUPY, Docteur	Contact	05 56 71 43 33		jerome.aupy@u-bordeaux.fr

Overall Officials

Name	Affiliation	Role
Jérôme AUPY, Docteur	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bordeaux	Recruiting	Bordeaux		33076	France

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D004827	Epilepsy
D012640	Seizures
D020820	Dyskinesias

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided