HealthyTECHNITIONNCT04566744
NeuroCognitive Bases of Tool Use
A study testing fRMI in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fRMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2021to 8 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be between the ages of 18 and 65 years old
- Having given an informed consent for the study
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CERMEP
Bron
François OSIURAK, PhD, 04 78 77 43 95 ext. +33, francois.osiurak@univ-lyon2.fr
Yves ROSSETTI, MD, 04 72 91 34 00 ext. +33, Yves.Rossetti@chu-lyon.fr
About this study
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.
- Conditions
- Healthy
- Being tested
- fRMI
- Keywords
- Tool use, fMRI, neuroimaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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; Receives: Other: fRMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start8 Nov 2021
- Primary completion8 Dec 2027 (estimated)
- Study completion8 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Université Lumière Lyon 2
- Responsible party
- Sponsor
- Investigators
- François OSIURAK, PhD, Principal investigator, Université Lyon 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566744
- Sponsor's protocol ID
- 69HCL20_0677
- Other IDs
- 2020-A02115-34
- Acronym
- TECHNITION
- Status last verified
- Jun 2024
- First submitted
- 22 Sep 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroCognitive Bases of Tool Use
- ClinicalTrials.gov ID
- NCT04566744
- Acronym / sponsor ID
- TECHNITION / 69HCL20_0677
- Conditions
- Healthy
- Keywords
- Tool use, fMRI, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Université Lumière Lyon 2
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 8 Dec 2027 (estimated)
- Study completion
- 8 Dec 2027 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical tool use, tool making and construction | Experimental | Other: fRMIThe 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. |
| Use of modern physical tools and stone tools | Experimental | Other: fRMIThe 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). |
| Use of modern physical, arbitrary and digital tools | Experimental | Other: fRMIThe 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. |
| Physical tool use and Internet | Experimental | Other: fRMIThe 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; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be between the ages of 18 and 65 years old
- Having given an informed consent for the study
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fRMIThe 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. | Other | Physical tool use and Internet, Physical tool use, tool making and construction, Use of modern physical tools and stone tools, Use of modern physical, arbitrary and digital tools |
Primary outcome
Blood Oxygenation Level Dependent measure
Time frame: 1 hour
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François OSIURAK, PhD principal investigator
Université Lyon 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fRMI in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François OSIURAK, PhD (04 78 77 43 95 ext. +33, francois.osiurak@univ-lyon2.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygenation Level Dependent measure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.