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Recruiting NCT06438419

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

No phase Interventional Parkinson Disease Hyperkinesis Hypokinesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrophysiological recordings.
Who it may be relevant to
Registry conditions: Parkinson Disease, Hyperkinesis, Hypokinesia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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).

Primary outcome measures

  • Cortico-subcortical electrophysiological coherence [Time frame: At inclusion (Day 0)]
Secondary outcome measures (3)
  • Spectral signal power [Time frame: At inclusion (Day 0)]
  • Effect of STN-DBS on spectral signal power [Time frame: At inclusion (Day 0)]
  • Correlation between semiological characteristics [Time frame: At inclusion (Day 0)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Bordeaux University Hospital — Bordeaux

Identifiers

NCT: NCT06438419 · CHUBX 2023/63

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗