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Multisensory Body and Space Representations (BASES-EXTINCTION)

Primary Purpose

Healthy, Blindness

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrooculogram (EOG)
Surface Electromyography (EMG)
Electrodermal response
Changes in skin temperature
MRI
MEG
Transcranial magnetic stimulation (TMS)
Transcranial electrical stimulation in direct current (tDCS)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Stroke, Multisensory, Plasticity, Body, Space, MRI

Eligibility Criteria

5 Years - 71 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female aged 5 to 71
  • Subject affiliated to the general social security scheme or a similar scheme
  • Subject agreeing to participate in the study with informed consent -Capable of understanding information and simple instructions related to the study

Exclusion Criteria:

  • Subject under tutelage or guardianship- Subject under tutelage or guardianship
  • Subject not able to give informed consent, unable to receive information about the study
  • Subject not affiliated to a French or non-French social security system holder of a European health insurance card

Sites / Locations

  • Hospices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Behavioral protocol

Study in fMRI

Study in MEG

Study in TMS

Study in tDCS

Arm Description

To better understand the normal functioning of the brain within the framework of the representation of the body and of the space of action. During the experiment, physiological measurements will be recorded: electrical activity at the surface of the muscles (electromyography - EMG), scalp (electroencephalography - EEG) or skin (electrodermal response). Similarly, the movements of the arm will be recorded using an infrared kinematic system requiring simply the placement of markers at strategic points such as the tip of the thumb and forefinger, the wrist, the elbow ... Movements of the eyes can also be recorded, either with the aid of an electrooculograph (EOG) or with the aid of an infrared tracking device. Electrotactile stimulations of very low intensity and painless can also be administered.

To better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the brain areas critical for these functions and to determine their functional roles. The examination will consist of several very short scans at the very beginning and then a scan of about ten minutes intended to take a detailed anatomical image of the brain. Then, the subject will carry out the experimental task during one or more scan (s) whose cumulative duration will not exceed 45 minutes. The task accomplished is explained in detail by the experimenter.

To better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the critical brain areas for these functions and to determine their functional roles and to study how They interact.The complete examination includes a magnetoencephalography (MEG) experiment followed by an MRI examination. The task accomplished is explained in detail by the experimenter.

To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the brain areas involved in these processes. Before the Transcranial magnetic stimulation (TMS) examination, MRI of the brain will be performed.The TMS review will consist of three distinct sessions separated from one another by at least one week, depending on the protocol, and which will differ simply at the site or type of stimulation.

To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the cerebral areas involved in these processes. The transcranial Direct Current Stimulation (tDCS) exam will consist of three separate sessions separated from each other by at least one week and will simply differ at the stimulation site. The task accomplished is explained in detail by the experimenter.

Outcomes

Primary Outcome Measures

Behavioural measure: reaction times
Mesure of reaction times.
Behavioural measure : accuracy
Mesure of accuracy. Measurement of the accuracy of the realization of the implicit and explicit tasks according to the different approaches.
Number of particpants with changed kinematics , via 3D optoelectronic motion tracking systems
Both latency and amplitude measures will be analysed for the presence of altered mouvement patterns in velocity, accelleration, deceleration of the arm and grip formation for the hand.

Secondary Outcome Measures

Physiological Indices
Mesure with imaging
Neuronal response indices
Bold, Evoked Fields, Evoked Potentials

Full Information

First Posted
March 29, 2017
Last Updated
July 19, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03201341
Brief Title
Multisensory Body and Space Representations (BASES-EXTINCTION)
Official Title
Cerebral Bases of Multisensory Perception of the Body and Its Action Space
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2011 (Actual)
Primary Completion Date
June 11, 2022 (Anticipated)
Study Completion Date
July 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Blindness
Keywords
Stroke, Multisensory, Plasticity, Body, Space, MRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral protocol
Arm Type
Other
Arm Description
To better understand the normal functioning of the brain within the framework of the representation of the body and of the space of action. During the experiment, physiological measurements will be recorded: electrical activity at the surface of the muscles (electromyography - EMG), scalp (electroencephalography - EEG) or skin (electrodermal response). Similarly, the movements of the arm will be recorded using an infrared kinematic system requiring simply the placement of markers at strategic points such as the tip of the thumb and forefinger, the wrist, the elbow ... Movements of the eyes can also be recorded, either with the aid of an electrooculograph (EOG) or with the aid of an infrared tracking device. Electrotactile stimulations of very low intensity and painless can also be administered.
Arm Title
Study in fMRI
Arm Type
Other
Arm Description
To better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the brain areas critical for these functions and to determine their functional roles. The examination will consist of several very short scans at the very beginning and then a scan of about ten minutes intended to take a detailed anatomical image of the brain. Then, the subject will carry out the experimental task during one or more scan (s) whose cumulative duration will not exceed 45 minutes. The task accomplished is explained in detail by the experimenter.
Arm Title
Study in MEG
Arm Type
Other
Arm Description
To better understand the normal functioning of the brain in the representation of the body and the space of action, to identify the critical brain areas for these functions and to determine their functional roles and to study how They interact.The complete examination includes a magnetoencephalography (MEG) experiment followed by an MRI examination. The task accomplished is explained in detail by the experimenter.
Arm Title
Study in TMS
Arm Type
Other
Arm Description
To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the brain areas involved in these processes. Before the Transcranial magnetic stimulation (TMS) examination, MRI of the brain will be performed.The TMS review will consist of three distinct sessions separated from one another by at least one week, depending on the protocol, and which will differ simply at the site or type of stimulation.
Arm Title
Study in tDCS
Arm Type
Other
Arm Description
To better understand the normal functioning of the brain in the representation of the body and the space of action, to determine the functional role of the cerebral areas involved in these processes. The transcranial Direct Current Stimulation (tDCS) exam will consist of three separate sessions separated from each other by at least one week and will simply differ at the stimulation site. The task accomplished is explained in detail by the experimenter.
Intervention Type
Other
Intervention Name(s)
Electrooculogram (EOG)
Other Intervention Name(s)
Eye-tracker
Intervention Description
The acquisition of the surface EOG activity will be carried out by means of 3 surface electrodes, one of which, referred to as a reference, is placed on a bone zone (the glabella, above the nasion) and two others placed on The temples, coupled to an EOG amplifier.
Intervention Type
Other
Intervention Name(s)
Surface Electromyography (EMG)
Intervention Description
In behavioral or transcranial stimulation protocols, surface EMG activity may be recorded for further analysis. No protocol included in this project will involve the recording of intramuscular electromyographic activity, which is invasive and involves the implantation of needle electrodes into the muscles.
Intervention Type
Other
Intervention Name(s)
Electrodermal response
Intervention Description
The electrodermal response is a useful, simple and reproducible method for recording sweat gland activity that reflects autonomic nervous activity. Recordings will be made using traditional devices, including an amplifier (Delsys or BrainAMP or equivalent) as well as disposable electrodes.
Intervention Type
Other
Intervention Name(s)
Changes in skin temperature
Intervention Description
The skin temperature will therefore be recorded during behavioral protocols using techniques for manipulating the representation of the body (perceptual illusion, prismatic deviation, etc.) using a specific measuring device.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Whatever the protocol, a diffusion tensor MRI (DTI) acquisition sequence as well as an image of the entire brain and high spatial resolution (T1 weight, 1x1x1 mm, nasion markers and pre-atrial points) will be acquired (Total duration: 20 minutes).
Intervention Type
Other
Intervention Name(s)
MEG
Intervention Description
During the examination, the subject will have to perform tasks comparable to those described for the fMRI procedure, but with the additional possibility, offered by the MEG environment, of performing pointing or seizing of objects, provided that the Trunk and the subject's head be held in place by a suitable restraint system.
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
TMS is a non-invasive technique that uses very short (~ 100μs) magnetic pulses applied to the scalp to transiently and focally disrupt or improve the functioning of neuronal populations in the underlying superficial cortical regions.
Intervention Type
Other
Intervention Name(s)
Transcranial electrical stimulation in direct current (tDCS)
Intervention Description
The tDCS consists in passing a current of low intensity (generally ≤ 1mA to stimulate the cerebral cortex) between an anode and a cathode placed on the scalp, a part of this current crossing the tissues, and in particular the cortical regions situated between these two Electrodes. Generally, if the cathode is placed on the region of interest, it will be inhibited, while it will be energized if the anode is positioned thereon.
Primary Outcome Measure Information:
Title
Behavioural measure: reaction times
Description
Mesure of reaction times.
Time Frame
Day 30
Title
Behavioural measure : accuracy
Description
Mesure of accuracy. Measurement of the accuracy of the realization of the implicit and explicit tasks according to the different approaches.
Time Frame
Day 30
Title
Number of particpants with changed kinematics , via 3D optoelectronic motion tracking systems
Description
Both latency and amplitude measures will be analysed for the presence of altered mouvement patterns in velocity, accelleration, deceleration of the arm and grip formation for the hand.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Physiological Indices
Description
Mesure with imaging
Time Frame
Day 30
Title
Neuronal response indices
Description
Bold, Evoked Fields, Evoked Potentials
Time Frame
Day 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female aged 5 to 71 Subject affiliated to the general social security scheme or a similar scheme Subject agreeing to participate in the study with informed consent -Capable of understanding information and simple instructions related to the study Exclusion Criteria: Subject under tutelage or guardianship- Subject under tutelage or guardianship Subject not able to give informed consent, unable to receive information about the study Subject not affiliated to a French or non-French social security system holder of a European health insurance card
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles RODE, MD
Phone
04 78 86 50 66
Ext
+33
Email
gilles.rode@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro FARNE, PhD
Phone
04 72 91 34 12
Ext
+33
Email
alessandro.farne@inserm.fr
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Saint Genis Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles RODE, MD
Phone
04 78 86 50 66
Ext
+33
Email
gilles.rode@chu-lyon.fr

12. IPD Sharing Statement

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Multisensory Body and Space Representations (BASES-EXTINCTION)

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