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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04727944
Other study ID # 69HCL20_0843
Secondary ID 2021-A00042-39
Status Recruiting
Phase N/A
First received
Last updated
Start date July 28, 2022
Est. completion date December 28, 2024

Study information

Verified date January 2024
Source Hospices Civils de Lyon
Contact James BONAIUTO, MD
Phone 06 49 34 87 61
Email james.bonaiuto@isc.cnrs.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The whole body's voluntary movements are controlled by the brain. One of the brain areas most involved in controlling these voluntary movements is the motor cortex and it is often viewed as the primary 'output' region of the neocortex. Motor cortical activity in the beta frequency range (13-30Hz) is a hallmark signature of healthy and pathological movement, but its behavioral relevance remains unclear. Such uncertainty confounds the development of treatments for diseases of movement which are associated with pathophysiological beta activity, including Parkinson's, therefore furthering understanding on the behavioral significance of activity in this range is now vital. Recently, it has become apparent that oscillatory beta activity actually occurs in discrete transient bursts, and that the summation of short-lasting, high-powered bursts of activity only appear to be sustained oscillations when averaged over multiple trials. In this study we will use neurophysiological and neuroimaging techniques such as electroencephalography (EEG), magnetoencephalography (MEG), and magnetic resonance imaging (MRI). All of these techniques have been identified as non-invasive techniques. By applying these methods, we will be able to analyze beta burst activity in order to determine how beta bursts influence naturalistic motor behavior. This project also encompasses the study of auditory and motor interactions doing an experimental task. The aim of the project is to get a better understanding of the role of motor-related beta activity during the preparation and generation of reach and grasp actions. These findings may inform novel treatments for pathophysiological disorders characterized by aberrant beta signaling, utilizing causal manipulation of the neural circuits implicated in the generation of beta activity. This project also has expected methodological repercussions. It will make it possible to validate the use of individualized head-casts worn during MEG acquisition for the study of the cortical control of naturalistic actions, and to create new analysis tools that allow an increase in the spatial resolution of MEG data.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 28, 2024
Est. primary completion date December 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: For all experiments : - Healthy male or female - Aged 18-40 years - Registered with the French healthcare system - Motivated to participate in the study - Normal or corrected vision - Right-handed - Adequate knowledge of French to be able to follow directions - Subjects must have the minimal motor ability necessary to participate in the experiment - Subjects must be able to listen and understand the study instructions - Subjects must be able to give written informed consent before participation - Normal hearing Exclusion Criteria: For all experiments : Subjects with characteristics incompatible with MEG/EEG and MRI : - Claustrophobia - Psychiatric pathology characterized including Alzheimer's disease, Parkinson's disease, multiple sclerosis (MS), or severe traumatic brain injury - Neuropsychological disorders or cognitive impairment including schizophrenia, bipolar disorder, seizures, epilepsy, sleep disorders - Regular use of neurodevelopment medicines (antidepressants, neuroleptics) - Subject has a history of skin disease or skin allergies (multiple or severe) - Subject working with metals in their professional lives - The subject had an MRI 2 weeks prior to experiment 1 - Implanted material (any dental apparatus containing metal including or root canals or any metallic object, pacemaker, cochlear implanted in the body) - Pregnant women or lactating women (based on self-report) - subjects who are not able to tolerate sitting for 1 hour (the estimated length of the experiment) - Alcohol dependence - Subjects who, in the opinion of the investigator are not able or willing to comply with the protocol For experiment 1: - A head size incompatible with the use of a personalized 3D head-cast or a magnetoencephalography

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reach and grasp tasks in healthy participants using MEG technique (Experiment 1)
Human participants will perform reach and grasp movements to various objects (e.g. a cube, sphere, or rod) driven either by perceived action affordances, or instruction cues. A rotating carousel will be used to present subjects with various objects affording different types of grasps (e.g. a precision pinch, a whole hand 'power' grasp, or a tripod grasp). Prior to the experiment, subjects will be tested outside the scanner by asking them to grasp each object as they would naturally to ensure that each object elicits the expected grasp type. Subject-specific, 3D-printed head-casts will be created based on high resolution MRI scans from each subject, and worn by subjects during the MEG experiment (Experiment 1) to reduce within-session head movement associated with reaching and grasping. At the end of this session an experimental task is added: detection of tons in presence of multitonal masks, in order to verify how beta peaks might be generated by a stimulus auditory.
Reach and grasp tasks in healthy participants using EEG technique (Experiment 2)
Experiment 2 consists of a task of reaching for and grasping several objects (e.g. a cube, sphere, or rod) ; the task used for experiment 2 is the same as that used for experiment 1. EEG signals will be measured.

Locations

Country Name City State
France Institut des Sciences Cognitives, Marc Jeannerod, UMR 5229 CNRS Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Timing of beta bursts in motor cortex, measured with MEG before initiation of a movement Timing (ms, relative to motion onset) of beta bursts in motor cortex with MEGthan the one planned is cued and must be performed. The data of subjects will be collected and analyzed through study completion an average of 2 years
Primary Spatial location of beta bursts in motor cortex, measured with MEG before initiation of a movement Spatial location (mm, in a brain-centered reference frame) of beta bursts in motor cortex, measured with MEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Primary Timing of beta bursts in motor cortex, measured with EEG before initiation of a movement Timing (ms, relative to motion onset) of beta bursts in motor cortex with EEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Primary Spatial location of beta bursts in motor cortex, measured with EEG before initiation of a movement Spatial location (mm, in a brain-centered reference frame) of beta bursts in motor cortex, measured with EEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Timing of beta bursts in motor cortex, measured with MEG before initiation of a movement Timing (ms, relative to motion onset) of beta bursts in motor cortex with MEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Spatial location of beta bursts in motor cortex, measured with MEG before initiation of a movement Spatial location (mm, in a brain-centered reference frame) of beta bursts in motor cortex, measured with MEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Timing of beta bursts in motor cortex, measured with EEG before initiation of a movement Timing (ms, relative to motion onset) of beta bursts in motor cortex with EEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Spatial location of beta bursts in motor cortex, measured with EEG before initiation of a movement Spatial location (mm, in a brain-centered reference frame) of beta bursts in motor cortex, measured with EEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Beta amplitude, measured with MEG Beta amplitude (fT) in motor cortex, measured with MEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Beta amplitude, measured with EEG Beta amplitude (µV) in motor cortex, measured with EEG The data of subjects will be collected and analyzed through study completion an average of 2 years
Secondary Determine what aspects of grasp kinematics can be decoded from beta burst activity in motor cortex and related regions. Multivariate machine learning models which are able to predict the trajectory of arm and hand kinematics from the spatiotemporal pattern of beta bursts in motor cortex. The data of subjects will be collected and analyzed through study completion an average of 2 years.
Secondary Within-session movement Movement (mm) of fiducial locations of the head-cast relative to the MEG sensors The data of subjects will be collected and analyzed through study completion an average of 2 years.
Secondary Visual stimuli Comparison of synchronization, localization and waveform of beta peaks in the motor cortex in response ovisual stimuli. The data of subjects will be collected and analyzed through study completion an average of 2 years.
Secondary Auditory stimuli Comparison of synchronization, localization and waveform of beta peaks in the motor cortex in response to auditory stimuli. The data of subjects will be collected and analyzed through study completion an average of 2 years.
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