Multisensory Body and Space Representations (BASES-EXTINCTION)

NCT ID: NCT03201341

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-11
• Study Completion Date: 2022-07-11

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.

Conditions

Healthy; Blindness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Behavioral protocol

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.

Group Type: OTHER

Electrooculogram (EOG)

Intervention Type: OTHER

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.

Surface Electromyography (EMG)

Intervention Type: OTHER

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.

Electrodermal response

Intervention Type: OTHER

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.

Changes in skin temperature

Intervention Type: OTHER

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.

Study in fMRI

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.

Group Type: OTHER

MRI

Intervention Type: OTHER

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).

Study in MEG

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.

Group Type: OTHER

MRI

Intervention Type: OTHER

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).

MEG

Intervention Type: OTHER

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.

Study in TMS

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.

Group Type: OTHER

MRI

Intervention Type: OTHER

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).

Transcranial magnetic stimulation (TMS)

Intervention Type: OTHER

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.

Study in tDCS

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.

Group Type: OTHER

Transcranial electrical stimulation in direct current (tDCS)

Intervention Type: OTHER

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.

Interventions

Electrooculogram (EOG)

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

Surface Electromyography (EMG)

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

Electrodermal response

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

Changes in skin temperature

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

MRI

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

MEG

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

Transcranial magnetic stimulation (TMS)

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

Transcranial electrical stimulation in direct current (tDCS)

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.

Intervention Type: OTHER

Other Intervention Names

Eye-tracker

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon

Saint-Genis-Laval, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gilles RODE, MD

Role: CONTACT

gilles.rode@chu-lyon.fr

04 78 86 50 66 ext. +33

Alessandro FARNE, PhD

Role: CONTACT

alessandro.farne@inserm.fr

04 72 91 34 12 ext. +33

Facility Contacts

Gilles RODE, MD

Role: primary

gilles.rode@chu-lyon.fr

04 78 86 50 66 ext. +33

Other Identifiers

69HCL16_0650

Identifier Type: -

Identifier Source: org_study_id