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

NCT ID: NCT06438419

Condition: Parkinson Disease
Hyperkinesis
Hypokinesia

Conditions: Official terms:
Ganglion Cysts
Parkinson Disease
Parkinsonian Disorders
Hypokinesia
Hyperkinesis

Conditions: Keywords:
Parkinson disease
hypokinetic disorders
dyskinesia
networks
basal ganglia

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Electrophysiological recordings
Description: 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).
Arm group label: Recruited patient

Summary: 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: 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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Bordeaux University Hospital

Address:
City: Bordeaux
Country: France

Contact:
Last name: Dominique Guehl, Pr
Email: dominique.guehl@chu-bordeaux.fr

Contact backup:
Last name: Claire BRANDET
Email: claire.brandet@chu-bordeaux.fr

Start date: June 2024

Completion date: June 2026

Lead sponsor:
Agency: University Hospital, Bordeaux
Agency class: Other

Collaborator:
Agency: Université de Bordeaux, IMN, UMR CNRS 5293
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/NCT06438419

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