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

April 29, 2025 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortico-subcortical electrophysiological coherence
Time Frame: At inclusion (Day 0)
Statistically significant difference in the cortico-subcortical electrophysiological coherence value between a movement performed in hypokinetic condition and a movement performed in hyperkinetic condition
At inclusion (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectral signal power
Time Frame: At inclusion (Day 0)
Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions.
At inclusion (Day 0)
Effect of STN-DBS on spectral signal power
Time Frame: At inclusion (Day 0)
Demonstration of a significant effect of STN-DBS on spectral signal power and cortico-subcortical synchronization during movement in hypokinetic or hyperkinetic conditions
At inclusion (Day 0)
Correlation between semiological characteristics
Time Frame: At inclusion (Day 0)
Demonstration of a statistical correlation between semiological characteristics (hypo- and hyperkinesia, movement parameters (reaction time and movement time)) and electrophysiological characteristics.
At inclusion (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Université de Bordeaux, IMN, UMR CNRS 5293

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2023/63

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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