- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241924
Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement (BAG-OSMOV)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 :
i) 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jérôme AUPY, Docteur
- Phone Number: 05 56 71 43 33
- Email: jerome.aupy@u-bordeaux.fr
Study Locations
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Bordeaux, France, 33076
- Recruiting
- CHU de Bordeaux
-
Contact:
- Jérôme Aupy
- Phone Number: 05 56 71 43 33
-
Contact:
- Olivier Branchard
- Phone Number: 05 57 82 06 97
- Email: olivier.branchard@chu-bordeaux.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria :
- 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.
- 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
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Epilepsy
|
Local field potentials (LFP) recording using sEEG
|
|
Experimental: parkinson disease
|
Local field potentials (LFP) recording using EEG-HR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jérôme AUPY, Docteur, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2022/80
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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