Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range

NCT ID: NCT06438419

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2027-04-30

Brief Summary

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Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task.

Detailed Description

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To define the link between the characteristics of neuronal oscillations (frequency, amplitude, phase relationship) within the cortico-subcortical network and the movement, we designed a simple motor task of gripping/pulling a lever. The LFPs will be collected at the cortical and subcortical levels (STN) during the motor task using a high-resolution EEG (HR-EEG) and the Percept™ system (Medtronic). Recordings will be realized in four conditions: without pharmacological treatment and without stimulation (Off condition), without pharmacological treatment and during stimulation (DBS condition), during pharmacological treatment and without stimulation (DOPA condition) and during pharmacological treatment and stimulation (DOPA+DBS condition).

Conditions

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Parkinson Disease Hyperkinesis Hypokinesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Recruited patient

Patient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation)

Group Type EXPERIMENTAL

Electrophysiological recordings

Intervention Type OTHER

Electrophysiological recordings will be made during a motor task in four different conditions:

1. without pharmacological treatment and without stimulation (Off condition),
2. without pharmacological treatment and during stimulation (DBS condition),
3. during pharmacological treatment and without stimulation (DOPA condition),
4. during pharmacological treatment and stimulation (DOPA+DBS condition).

Interventions

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Electrophysiological recordings

Electrophysiological recordings will be made during a motor task in four different conditions:

1. without pharmacological treatment and without stimulation (Off condition),
2. without pharmacological treatment and during stimulation (DBS condition),
3. during pharmacological treatment and without stimulation (DOPA condition),
4. during pharmacological treatment and stimulation (DOPA+DBS condition).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or Female
* 18 to 75 years-old
* With idiopathic Parkinson's disease
* Having a STN-DBS with a PERCEPT™ for less than a year or being candidate for STN-DBS with the PERCEPT™ device (first-implantation)
* Able to perform the simple motor task
* Patients covered by a health insurance 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 (curatorship, guardianship) or be placed under judicial protection.
* Being pregnant or breastfeeding
* Present a serious and/or decompensated somatic or psychiatric illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Bordeaux, IMN, UMR CNRS 5293

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bordeaux University Hospital

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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GUEHL Dominique, Pr

Role: CONTACT

5 57 82 12 42 ext. +33

Claire BRANDET

Role: CONTACT

Facility Contacts

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Dominique Guehl, Pr

Role: primary

Claire BRANDET

Role: backup

Other Identifiers

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CHUBX 2023/63

Identifier Type: -

Identifier Source: org_study_id

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