Clinical trial NCT06438419: Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range
Official title: Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Hyperkinesis
Hypokinesia
Keywords: Parkinson disease
hypokinetic disorders
dyskinesia
networks
basal ganglia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Université de Bordeaux, IMN, UMR CNRS 5293
First posted: 2024-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Cortico-subcortical electrophysiological coherence
timeFrame: At inclusion (Day 0)
Secondary outcomes:
measure: Spectral signal power
timeFrame: At inclusion (Day 0)
measure: Effect of STN-DBS on spectral signal power
timeFrame: At inclusion (Day 0)
measure: Correlation between semiological characteristics
timeFrame: At inclusion (Day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
References: