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Clinical Trials/NCT06438419
NCT06438419
Recruiting
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country20 target enrollmentApril 16, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University Hospital, Bordeaux
Enrollment
20
Locations
1
Primary Endpoint
Cortico-subcortical electrophysiological coherence
Status
Recruiting
Last Updated
last year

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
April 16, 2025
End Date
April 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Sites (1)

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