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NCT Number: NCT06438419

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Hyperkinesis Hypokinesia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital

Bordeaux, France

Location status: Recruiting

Location contact

Claire BRANDET

CONTACT

[email protected]

Dominique Guehl, Pr

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrophysiological recordings

Other

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).

Primary outcomes

  1. 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

  1. Spectral signal power

    Time frame: At inclusion (Day 0)

    Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions.

  2. Effect of STN-DBS on spectral signal power

    Time frame: At inclusion (Day 0)

    Demonstration of a significant effect of STN-DBS on spectral signal power and cortico-subcortical synchronization during movement in hypokinetic or hyperkinetic conditions

  3. Correlation between semiological characteristics

    Time frame: At inclusion (Day 0)

    Demonstration of a statistical correlation between semiological characteristics (hypo- and hyperkinesia, movement parameters (reaction time and movement time)) and electrophysiological characteristics.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire BRANDET

CONTACT

[email protected]

GUEHL Dominique, Pr

CONTACT

[email protected]

5 57 82 12 42 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Université de Bordeaux, IMN, UMR CNRS 5293

Registry information

Acronym: MOVOSCILLCBGT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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