Multisensory Body and Space Representations (BASES-EXTINCTION)

Healthy Clinical Trial

Official title:

Cerebral Bases of Multisensory Perception of the Body and Its Action Space

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201341
• Other study ID #: 69HCL16_0650
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2011
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: Gilles RODE, MD
• Phone: 04 78 86 50 66
• Email: gilles.rode[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1540
• Est. completion date: July 11, 2022
• Est. primary completion date: June 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Healthy

Intervention

Other:
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Saint Genis Laval

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	Behavioural measure: reaction times	Mesure of reaction times.	Day 30
Primary	Behavioural measure : accuracy	Mesure of accuracy. Measurement of the accuracy of the realization of the implicit and explicit tasks according to the different approaches.	Day 30
Primary	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.	Day 30
Secondary	Physiological Indices	Mesure with imaging	Day 30
Secondary	Neuronal response indices	Bold, Evoked Fields, Evoked Potentials	Day 120