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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03453216
Other study ID # 2016-A01477-44
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date September 30, 2023

Study information

Verified date January 2022
Source Hôpital le Vinatier
Contact VIAL VERONIQUE
Phone 0033437915531
Email veronique.vial@ch-le-vinatier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In a recent study, investigators provided the first neuroscientific data on social facilitation. This neuroimaging study, performed in the macaque monkey, shows a marked improvement in performance in a simple task when a congener is present compared to when the animal performs the task alone. This social facilitation is accompanied by a significant increase in brain activity within the fronto-parietal network of attention. No variation in activity, however, is observed in the cerebral network of motivation. These results argue in favor of the implication of attentional processes in the phenomenon of social facilitation. The challenge now is to determine whether social facilitation is always based on the attention network (whatever the task) or, alternatively, whether it increases activity in any cerebral circuit involved depending on the task performed and the population studied. This hypothesis, which the investigators have named the "multi-mediator model of social facilitation", has the advantage of reconciling the attentional and motivational theories of social facilitation, which are not mutually exclusive. This hypothesis also provides an explanation for the pervasiveness (across species and different ages for humans) of social facilitation. The main objective of SOFEE is to gather neuroscientific evidence to support the multi-facilitator model of social facilitation.


Description:

The main objective is to study the effect of the presence of others on cognitive performance and its evolution during development by behavioral and neural measures. The secondary objective is to identify factors (psychological characteristics such as personality traits) explaining individual, behavioral and neural differences, sensitivity to the presence of others.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date September 30, 2023
Est. primary completion date April 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 35 Years
Eligibility Inclusion Criteria: - Girl or boy aged = 8 years and = 12 years old for children, - Girl or boy aged = 13 years and = 19 years old for teenagers, - Woman or man age = 20 years and = 35 years old for young adults, - French mother tongue, - With the right to a social security scheme or similar, - With informed consent form signed by the legal representatives and the subject, for minors, - Has signed the informed consent form, for adults. Exclusion Criteria: - Known acquired neurological disorders, including epilepsy, - Known psychiatric disorders, - Complications at birth requiring admission to neonatal intensive care unit, - Ongoing treatment with drugs affecting the central nervous system, - Significant hearing impairment, - Uncorrected visual inadequacy, - Left manual preference, - Contraindications to the MRI examination (people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects), - Refusal of the subject or parents of the subject to be informed of any anomalies detected on the MRI, - Pregnancy for women of childbearing age: the possibility of pregnancy will be ruled out on questioning for inclusion, - Protected persons other than children

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
neuropsychological tests
Part 1: to determine the cognitive capacity, the subjects undergo different neuropsychological tests To determine individual characteristics children, adolescents and adults complete self-assessment questionnaires . Adults spend a semi-directive interview. Part 2: while the subject 1 (S1) is installed in the MRI, he perform behavioral tasks with the subject 2 (S2) (familiar peer of the same age ± 2 years) installed in an adjacent room, alternating periods when S1 is observed by S2 (condition "Social") and periods when S1 is not observed by S2 (condition "Alone").

Locations

Country Name City State
France CH Le Vinatier BRON Cedex Rhône-Alpes

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral performance evaluation percentage of correct answers and reaction time when performing cognitive number and rhyme comparison tasks in the presence or absence of a familiar peer an average of 5 years
Primary identification through Functional Magnetic Resonance Imaging (fMRI ) of brain activity related to the presence of others Comparison of activity in the three populations tested (children, adolescents, adults) an average of 5 years
Secondary Determination of individual characteristics answers of self-assessment questionnaires and semi-directive interview an average of 5 years
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