- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727944
Evaluation of Motor-Related Beta-Activity in Relation to Naturalistic Movement in Healthy Adult Subjects (MOBETA)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bron, France, 69500
- Institut des Sciences Cognitives, Marc Jeannerod, UMR 5229 CNRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: MEG and EEG recordings on Healthy volunteers
All subjects can participate in experiment 1 and/or 2. All analyses are intra-subject (no analyses are between-subject).
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Timing of beta bursts in motor cortex, measured with MEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
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Timing (ms, relative to motion onset) of beta bursts in motor cortex with MEGthan the one planned is cued and must be performed.
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The data of subjects will be collected and analyzed through study completion an average of 2 years
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Spatial location of beta bursts in motor cortex, measured with MEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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
|
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Timing of beta bursts in motor cortex, measured with EEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
Timing (ms, relative to motion onset) of beta bursts in motor cortex with EEG
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The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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Spatial location of beta bursts in motor cortex, measured with EEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
Spatial location (mm, in a brain-centered reference frame) of beta bursts in motor cortex, measured with EEG
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The data of subjects will be collected and analyzed through study completion an average of 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spatial location of beta bursts in motor cortex, measured with MEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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
|
|
Timing of beta bursts in motor cortex, measured with EEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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
|
|
Spatial location of beta bursts in motor cortex, measured with EEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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
|
|
Timing of beta bursts in motor cortex, measured with MEG before initiation of a movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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
|
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Beta amplitude, measured with MEG
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
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Beta amplitude (fT) in motor cortex, measured with MEG
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The data of subjects will be collected and analyzed through study completion an average of 2 years
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Beta amplitude, measured with EEG
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years
|
Beta amplitude (μV) in motor cortex, measured with EEG
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The data of subjects will be collected and analyzed through study completion an average of 2 years
|
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Determine what aspects of grasp kinematics can be decoded from beta burst activity in motor cortex and related regions.
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years.
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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.
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The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Within-session movement
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Movement (mm) of fiducial locations of the head-cast relative to the MEG sensors
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The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Visual stimuli
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Comparison of synchronization, localization and waveform of beta peaks in the motor cortex in response ovisual stimuli.
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The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Auditory stimuli
Time Frame: The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Comparison of synchronization, localization and waveform of beta peaks in the motor cortex in response to auditory stimuli.
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The data of subjects will be collected and analyzed through study completion an average of 2 years.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James BONAIUTO, Institut des Sciences Cognitives, Marc Jeannerod, UMR 5229 CNRS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 69HCL20_0843
- 2021-A00042-39 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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