- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453216
Impact of Another Person's Presence on Brain and Behavioral Performance (SOFEE)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhône-Alpes
-
BRON Cedex, Rhône-Alpes, France, 69678
- CH Le Vinatier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral test and fMRI
Neuropsychological tests and training in behavioral tasks and a Functional Magnetic Resonance Imaging (fMRI) exam
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
an average of 5 years
|
|
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)
|
an average of 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of individual characteristics
Time Frame: an average of 5 years
|
answers of self-assessment questionnaires and semi-directive interview
|
an average of 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: POISSON ALICE, MD, CH Le Vinatier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016-A01477-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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