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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04566744
Other study ID # 69HCL20_0677
Secondary ID 2020-A02115-34
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2020
Est. completion date February 2024

Study information

Verified date December 2020
Source Hospices Civils de Lyon
Contact François OSIURAK, PhD
Phone 04 78 77 43 95
Email francois.osiurak@univ-lyon2.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tool use is considered to be the hallmark of complex cognitive adaptations that humans have achieved trough evolution, that provides an adaptive advantage to the human species. Even if nonhuman species do use tools too, human tool use is much more complex and sophisticated. If humans have special abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans and nonhumans share a similar prehension system located within the superior parietal lobe and the intraparietal sulcus. However, there is a human specificity: the supramarginal gyrus within the left inferior parietal lobe is unique to humans, and could play a central role in tool use. This project aims to study the neurocognitive bases of human tool use with functional Magnetic Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able to use tools.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date February 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - To be between the ages of 18 and 65 years old - Having given an informed consent for the study Exclusion Criteria: - Pregnant or breastfeeding woman - Persons under curators or deprived of civil rights or deprived of their freedom - Not being registered with the French Social Security System - Not able to read/write the French - Neurologic or psychiatric illness, known or revealed during the inclusion visit - Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment - Noise intolerance - Unable to fill a questionnaire (severe cognitive troubles) - Not willing that their personal doctor to be informed in case of a MRI anomaly. - Not willing to be informed in case of MRI anomaly - Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, pellets, shrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup - Not willing to complete the study - Appearance of a exclusion criterion during the protocol - Appearance of an undesirable event preventing the completion of the protocol - Too great head movements (>4mm for the session) - Detection of artifacts in the brain images collected

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fRMI
The measurements performed will be the participant's brain activity, as well as behavioral measurements associated with the tasks performed (response time, correctness of the response). Brain activity measurements will be performed on the Siemens 3T system of the MRI department of CERMEP. The subject will perform the task under study while the level of brain activity is recorded. The functional examination will be subdivided into several parts according to its total length in order to spare the subject. The total duration of MRI acquisitions will be approximately 1 hour regardless of the axis.

Locations

Country Name City State
France CERMEP Bron

Sponsors (2)

Lead Sponsor Collaborator
Hospices Civils de Lyon Université Lumière Lyon 2

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Oxygenation Level Dependent measure The primary outcome measure will be the Blood Oxygenation Level Dependent measure (BOLD) as permitted with functional Magnetic Resonance Imaging.This BOLD level will be collected for every voxel in the imaged brain, and at regular time intervals (TR = 3s) during the experimental session (about one hour). This is standard procedure for fMRI experiments. FMRI measures brain activity by detecting changes associated with blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. The primary form of fMRI uses the BOLD contrast in response to an experimental condition (Ogawa, Lee, Kay, & Tank, 1990), allowing researchers to track changes in oxygen consumption on the brain and therefore brain activity. BOLD effefct is computed by assessing the different relaxation times (T1 and T2) in the brain, as T1 and T2 are different in function of regional cerebral blood flows 1 hour
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