Impact of Another Person's Presence on Brain and Behavioral Performance

Behavior and Behavior Mechanisms Clinical Trial

— SOFEE  

Official title:

Impact of the Presence of a Familiar Peer of the Same Age on the Behavioral Performance of the Child, Adolescent, and Young Adult and Study of the Biological Correlates by Neuroimagery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453216
• Other study ID #: 2016-A01477-44
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

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