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

Parkinson Disease Clinical Trial

— MOVOSCILLCBGT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438419
• Other study ID #: CHUBX 2023/63
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: University Hospital, Bordeaux
• Contact: GUEHL Dominique, Pr
• Phone: 5 57 82 12 42
• Email: dominique.guehl[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Hyperkinesis
• Hypokinesia
• Parkinson Disease
• Parkinsonian Disorders

Intervention

Other:
• Electrophysiological recordings
Electrophysiological recordings will be made during a motor task in four different 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), during pharmacological treatment and stimulation (DOPA+DBS condition).

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Université de Bordeaux, IMN, UMR CNRS 5293

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Spectral signal power	Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions.	At inclusion (Day 0)
Secondary	Effect of STN-DBS on spectral signal power	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)
Secondary	Correlation between semiological characteristics	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)