Parkinson DiseaseMOVOSCILLCBGTNCT06438419
Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range
A study testing Electrophysiological recordings in people with Parkinson Disease and Hyperkinesis, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Hyperkinesis, Hypokinesia
- What is being tested?
- Electrophysiological recordings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claire BRANDET contact
France1 site, 1 recruiting
- Recruiting
Bordeaux University Hospital
Bordeaux
Dominique Guehl, Pr, dominique.guehl@chu-bordeaux.fr
Claire BRANDET, claire.brandet@chu-bordeaux.fr
About this study
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.
Read the 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).
- Conditions
- Parkinson Disease, Hyperkinesis, Hypokinesia
- Being tested
- Electrophysiological recordings
- Keywords
- Parkinson disease, hypokinetic disorders, dyskinesia, networks, basal ganglia
- Medical subject headings
- Parkinson Disease, Hyperkinesis, Hypokinesia, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological recordingsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Recruited patient | Experimental | Patient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation) Receives: Other: Electrophysiological recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion (Day 0)
Secondary outcomes (3)
Spectral signal power
Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions.
Measured: At inclusion (Day 0)
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
Measured: At inclusion (Day 0)
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.
Measured: At inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start16 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Bordeaux, IMN, UMR CNRS 5293
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438419
- Sponsor's protocol ID
- CHUBX 2023/63
- Acronym
- MOVOSCILLCBGT
- Status last verified
- Apr 2025
- First submitted
- 27 May 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range
- ClinicalTrials.gov ID
- NCT06438419
- Acronym / sponsor ID
- MOVOSCILLCBGT / CHUBX 2023/63
- Conditions
- Parkinson Disease, Hyperkinesis, Hypokinesia
- Keywords
- Parkinson disease, hypokinetic disorders, dyskinesia, networks, basal ganglia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Université de Bordeaux, IMN, UMR CNRS 5293
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruited patient | Experimental | Other: Electrophysiological recordingsPatient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological recordingsElectrophysiological 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). | Other | Recruited patient |
Primary outcome
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
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire BRANDET contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological recordings in people with Parkinson Disease and Hyperkinesis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GUEHL Dominique, Pr (5 57 82 12 42 ext. +33, dominique.guehl@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortico-subcortical electrophysiological coherence (time frame: At inclusion (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.