NCT03453216

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

February 14, 2018

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Determination of individual characteristics

    an average of 5 years

Study Arms (1)

Behavioral test and fMRI

EXPERIMENTAL

Neuropsychological tests and training in behavioral tasks and a Functional Magnetic Resonance Imaging (fMRI) exam

Behavioral: neuropsychological tests

Interventions

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").

Also known as: Functional Magnetic Resonance Imaging (fMRI) exam
Behavioral test and fMRI

Eligibility Criteria

Age8 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • Protected persons other than children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Behavior

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • POISSON ALICE, MD

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2018

First Posted

March 5, 2018

Study Start

July 1, 2019

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

August 5, 2025

Record last verified: 2025-07

Locations