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

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ClinicalTrials.gov Identifier: NCT03453216
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Study Description
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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.

Condition or disease Intervention/treatment Phase
Behavior and Behavior Mechanisms Behavioral: neuropsychological tests Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : April 3, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Behavioral test and fMRI
Neuropsychological tests and training in behavioral tasks and a Functional Magnetic Resonance Imaging (fMRI) exam
 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").

Other Name: Functional Magnetic Resonance Imaging (fMRI) exam


Outcome Measures
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Primary Outcome Measures :
  1. Behavioral performance evaluation [ Time Frame: an average of 5 years ]
    percentage of correct answers and reaction time when performing cognitive number and rhyme comparison tasks in the presence or absence of a familiar peer

  2. identification through Functional Magnetic Resonance Imaging (fMRI ) of brain activity related to the presence of others [ Time Frame: an average of 5 years ]
    Comparison of activity in the three populations tested (children, adolescents, adults)


Secondary Outcome Measures :
  1. Determination of individual characteristics [ Time Frame: an average of 5 years ]
    answers of self-assessment questionnaires and semi-directive interview


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453216


Contacts
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Contact: VIAL VERONIQUE 0033437915531 veronique.vial@ch-le-vinatier.fr
Contact: Meunier Martine, MD 0033472913407 martine.meunier@inserm.fr

Locations
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France
CH Le Vinatier Recruiting
BRON Cedex, Rhône-Alpes, France, 69678
Contact: POISSON ALICE, PH    0437915163    alice.poisson@ch-le-vinatier.fr   
Contact: VIAL VERONIQUE    0437915531    veronique.vial@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: POISSON ALICE, MD CH LE VINATIER
More Information
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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT03453216    
Other Study ID Numbers: 2016-A01477-44
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No