Parkinson DiseaseBAG-OSMOVNCT06241924
Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement
A study testing High Resolution Electroencephalogram (EEG-HR) and Stereo-electro-encephalography (SEEG) in people with Parkinson Disease and Epilepsy, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this 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, Epilepsy
- What is being tested?
- High Resolution Electroencephalogram (EEG-HR) and Stereo-electro-encephalography (SEEG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 5 Feb 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
- Between 18 and 75 years of age
- With Parkinson's disease and already operated with implantation of electrodes in the Subthalamic nucleus connected to a PERCEPT (TM) device.
- Giving free, informed, written consent signed by the participant and the investigator Or
- With drug-resistant epilepsy and benefiting from a phase II pre-surgical assessment with intracerebral electrophysiological exploration by stereo-EEG
- With at least one electrode exploring the basal ganglia or the thalamus.
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- Able to perform the simple motor task
- Affiliated or beneficiary of a social security 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 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.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
Jérôme Aupy, 05 56 71 43 33
Olivier Branchard, 05 57 82 06 97, olivier.branchard@chu-bordeaux.fr
About this study
The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this cortico-subcortical network with a wide frequency range.
The purpose of this research is to study cortico-subcortical oscillations and their synchronization in two pathologies emblematic of hypokinetic (Parkinson's disease) and hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different situations.
Read the detailed description
In order to define the link between the characteristics of the oscillations (frequency, amplitude, phase relation) within this cortico-subcortical network and movement (normal or pathological) in humans, a simple motor task of gripping/pulling a lever has been designed.
The local field potentials (LFPs) will be collected during the same motor task in :
- patients with Parkinson's disease, using a high-resolution electroencephalogram (EEG) and the PERCEPT(TM) system (Medtronic) equipped with a "sensing" function for deep LFP recordings and in EEG-HR (for high resolution) for cortical recordings ii) patients with focal drug-resistant epilepsy, during a pre-surgical assessment by stereo-electro-encephalography (SEEG). The SEEG allows the recording of both the cortex and the subcortical regions in a concomitant manner, and a direct correlation can be studied.
- Conditions
- Parkinson Disease, Epilepsy
- Being tested
- High Resolution Electroencephalogram (EEG-HR), Stereo-electro-encephalography (SEEG)
- Keywords
- Focal seizure, Parkinson disease, Hyperkinetic seizures, Hypokinetic disorders, Dyskinesia, Networks, Basal ganglia
- Medical subject headings
- Parkinson Disease, Epilepsy, Seizures, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Electroencephalogram (EEG-HR)Procedure or surgery
Local field potentials (LFP) recording using EEG-HR
Stereo-electro-encephalography (SEEG)Procedure or surgery
Local field potentials (LFP) recording using sEEG
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Experimental | Not described Receives: Procedure: Stereo-electro-encephalography (SEEG) |
| parkinson disease | Experimental | Not described Receives: Procedure: High Resolution Electroencephalogram (EEG-HR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the cortico-subcortical electrophysiological coherence value
difference in the cortico-subcortical electrophysiological coherence value between normal movement (control condition) and hypo- or hyperkinetic pathological movement
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Feb 2024
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme AUPY, Docteur, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241924
- Sponsor's protocol ID
- CHUBX 2022/80
- Acronym
- BAG-OSMOV
- Status last verified
- Jul 2025
- First submitted
- 26 Jan 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement
- ClinicalTrials.gov ID
- NCT06241924
- Acronym / sponsor ID
- BAG-OSMOV / CHUBX 2022/80
- Conditions
- Parkinson Disease, Epilepsy
- Keywords
- Focal seizure, Parkinson disease, Hyperkinetic seizures, Hypokinetic disorders, Dyskinesia, Networks, Basal ganglia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 5 Feb 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.
The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this cortico-subcortical network with a wide frequency range.
The purpose of this research is to study cortico-subcortical oscillations and their synchronization in two pathologies emblematic of hypokinetic (Parkinson's disease) and hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different situations.
Detailed description
In order to define the link between the characteristics of the oscillations (frequency, amplitude, phase relation) within this cortico-subcortical network and movement (normal or pathological) in humans, a simple motor task of gripping/pulling a lever has been designed.
The local field potentials (LFPs) will be collected during the same motor task in :
- patients with Parkinson's disease, using a high-resolution electroencephalogram (EEG) and the PERCEPT(TM) system (Medtronic) equipped with a "sensing" function for deep LFP recordings and in EEG-HR (for high resolution) for cortical recordings ii) patients with focal drug-resistant epilepsy, during a pre-surgical assessment by stereo-electro-encephalography (SEEG). The SEEG allows the recording of both the cortex and the subcortical regions in a concomitant manner, and a direct correlation can be studied.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | Experimental | Procedure: Stereo-electro-encephalography (SEEG) |
| parkinson disease | Experimental | Procedure: High Resolution Electroencephalogram (EEG-HR) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female
- Between 18 and 75 years of age
- With Parkinson's disease and already operated with implantation of electrodes in the Subthalamic nucleus connected to a PERCEPT (TM) device.
- Giving free, informed, written consent signed by the participant and the investigator Or
- With drug-resistant epilepsy and benefiting from a phase II pre-surgical assessment with intracerebral electrophysiological exploration by stereo-EEG
Key exclusion criteria (4 listed)
- Be incapable of giving consent personally
- Be subject to a legal protection measure 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 |
|---|---|---|
| High Resolution Electroencephalogram (EEG-HR)Local field potentials (LFP) recording using EEG-HR | Procedure or surgery | parkinson disease |
| Stereo-electro-encephalography (SEEG)Local field potentials (LFP) recording using sEEG | Procedure or surgery | Epilepsy |
Primary outcome
difference in the cortico-subcortical electrophysiological coherence value
Time frame: Day 1
difference in the cortico-subcortical electrophysiological coherence value between normal movement (control condition) and hypo- or hyperkinetic pathological movement
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 23 Jul 2025.
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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.
Jérôme AUPY, Docteur principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Resolution Electroencephalogram (EEG-HR) and Stereo-electro-encephalography (SEEG) in people with Parkinson Disease and Epilepsy, 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 9 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 23 Jul 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 Jérôme AUPY, Docteur (05 56 71 43 33, jerome.aupy@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the cortico-subcortical electrophysiological coherence value (time frame: Day 1). 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 23 Jul 2025.