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

NCT06438419 | Recruiting

• 1 other identifier: CHUBX 2023/63
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Hyperkinesis; Hypokinesia

Keywords

Parkinson disease; hypokinetic disorders; dyskinesia; networks; basal ganglia

Outcome Measures

Primary Outcomes (1)

• Cortico-subcortical electrophysiological coherence

  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 Outcomes (3)

• Spectral signal power

  At inclusion (Day 0)

• Effect of STN-DBS on spectral signal power

  At inclusion (Day 0)

• Correlation between semiological characteristics

  At inclusion (Day 0)

Study Arms (1)

Recruited patient

EXPERIMENTAL

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

Interventions

Electrophysiological recordings 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).

Recruited patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Université de Bordeaux, IMN, UMR CNRS 5293: collaborator

Study Sites (1)

Bordeaux University Hospital

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Hyperkinesis; Hypokinesia; Dyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

GUEHL Dominique, Pr

CONTACT

5 57 82 12 42; dominique.guehl@chu-bordeaux.fr

Claire BRANDET

CONTACT

claire.brandet@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)