ClinicalTrials.gg
TerminatedNCT03453216SOFEEUpdated Aug 5, 2025

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

An interventional study of neuropsychological tests in Behavior and Behavior Mechanisms, sponsored by Hôpital le Vinatier. Terminated at 1 site in France. Open to participants aged 8 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Basic science

Why this study was terminated
Investigator Departure
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Not applicable
Ages
8 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Behavior and Behavior Mechanisms

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03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 112 is close to the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form signed by the legal representatives and the subject, for minors,
  • Has signed the informed consent form, for adults.

Exclusion criteria

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,
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    Behavioral test and fMRI

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

    Behavioral: neuropsychological tests

Interventions

  • Behavioralneuropsychological 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").

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: an average of 5 years

  2. 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)

    Time frame: an average of 5 years

Secondary outcomes

  1. Determination of individual characteristics

    answers of self-assessment questionnaires and semi-directive interview

    Time frame: an average of 5 years

07

Study locations

1 site
  • CH Le Vinatier
    Bron, Auvergne-Rhône-Alpes 69678, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Oct 2022, 39 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2018
First posted
Mar 5, 2018
StartActual
Jul 1, 2019
Primary completionActual
Oct 5, 2022
CompletionActual
Oct 5, 2022
Last update
Aug 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03453216
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Jul 1, 2019
Primary completion
Oct 5, 2022
Completion
Oct 5, 2022
Last update
Aug 5, 2025

Study contacts

POISSON ALICE, MD
principal investigator · CH LE VINATIER

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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