Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06241924
Other study ID # CHUBX 2022/80
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2024
Est. completion date February 5, 2027

Study information

Verified date February 2024
Source University Hospital, Bordeaux
Contact Jérôme AUPY, Docteur
Phone 05 56 71 43 33
Email jerome.aupy@u-bordeaux.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 5, 2027
Est. primary completion date February 5, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
High Resolution Electroencephalogram (EEG-HR)
Local field potentials (LFP) recording using EEG-HR
Stereo-electro-encephalography (SEEG)
Local field potentials (LFP) recording using sEEG

Locations

Country Name City State
France CHU de Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A