NCT04566744

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable healthy

Timeline
19mo left

Started Nov 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Nov 2021Dec 2027

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2027

Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

6.1 years

First QC Date

September 22, 2020

Last Update Submit

June 24, 2024

Conditions

Keywords

Tool usefMRIneuroimaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Physical tool use, tool making and construction

EXPERIMENTAL

The fMRI experimental conditions in this arm will allow us to study the activity of the brain when solving mechanical problems in using either a physical tool, making a physical tool or building a construction. Only the fMRI experimental session is necessary. These experimental conditions related to the BOLD measures given by the fMRI technique will allow us to draw hypotheses on the neurocognitive mechanisms at work when we use or make physical tools as well as when we build constructions.

Other: fRMI

Use of modern physical tools and stone tools

EXPERIMENTAL

The fMRI experimental conditions in this arm will allow us to study the activity of the brain when solving mechanical problems in using either a modern physical tool or a stone tool. Only the fMRI experimental session is necessary. These experimental conditions related to the BOLD measures given by the fMRI technique will allow us to draw hypotheses on the neurocognitive mechanisms at work when we use or make physical tools irrespective of whether they are modern or old (i.e., stone tools).

Other: fRMI

Use of modern physical, arbitrary and digital tools

EXPERIMENTAL

The fMRI experimental conditions in this arm will allow us to study the activity of the brain when watching video clips of individuals using either a modern physical tool, an arbitrary tool (e.g., a washing machine) or a digital tool (e.g., a touchscreen). Only the fMRI experimental session is necessary. These experimental conditions related to the BOLD measures given by the fMRI technique will allow us to draw hypotheses on the neurocognitive mechanisms at work when we observe others using different kinds of tools, which have appeared progressively over technological evolution.

Other: fRMI

Physical tool use and Internet

EXPERIMENTAL

The fMRI experimental conditions in this arm will allow us to study the activity of the brain when estimating the capacity to solve a mechanical problem with modern physical tools either alone or with the help of a Internet Tutorial. Only the fMRI experimental session is necessary. These experimental conditions related to the BOLD measures given by the fMRI technique will allow us to draw hypotheses on the neurocognitive mechanisms at work when we imagine and estimate solving a mechanical problem alone or with the help of the Internet;

Other: fRMI

Interventions

fRMIOTHER

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.

Physical tool use and InternetPhysical tool use, tool making and constructionUse of modern physical tools and stone toolsUse of modern physical, arbitrary and digital tools

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be between the ages of 18 and 65 years old
  • Having given an informed consent for the study

You may not qualify if:

  • 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
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CERMEP

Bron, France

RECRUITING

Study Officials

  • François OSIURAK, PhD

    Université Lyon 2

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

November 8, 2021

Primary Completion (Estimated)

December 8, 2027

Study Completion (Estimated)

December 8, 2027

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations