Clinical trial NCT05577533: Digital Epidemiology Study on Brain Functioning
Official title: Digital Epidemiology Study on Brain Functioning in Children Aged 7 to 12 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Child Development Disorder
Keywords: Digital Epidemiology
Child
Neurodevelopment
Neurodevelopmental disorders
Mental disorders
Lead sponsor: O-Kidia
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 736
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Neurobiology has improved the integrative understanding of brain development. With digital technologies, digital (bio)markers would be relevant variables for a better understanding of the heterogeneity of cognitive and behavioral functioning in developing children.

However, the dominant statistical approach of group comparison tends to ignore intragroup variability. Applying high-dimensional data sets through multivariate methods and then combining their scores via predictive model learning algorithms would allow the identification of subtypes. Thus, EPIDIA4KIDS wants to understand the brain functioning of children aged 7 to 12 years old from heterogeneous data sources collected from a touchscreen tablet.

Detailed description: The overall objective of the EPIDIA4KIDS study is to understand brain functioning in children aged 7 to 12 years from heterogeneous digital data collected with a touch tablet. The investigators want to develop a digital e-screening, similarly to a blood test result, for cognitive, emotional and behavioral performances in children from 7 to 12 years old, resulting from a multimodal and multi-stream analysis generated by an artificial intelligence algorithm.

The main aims are therefore to:

* Develop a normative base of cognitive, emotional and, behavioral performances with children aged 7 to 12 years old using our digital tool.
* Examine the validity of our e-assessment by comparing the generated results to those obtained with standard measures of convergent validity.

Eligibility criteria: Inclusion Criteria:

* Boys or girls
* Aged 7 to 12 years
* Fluent in the French language
* Agreement and signature of informed consent by the child
* Agreement and signature of informed consent by one of the legal representatives
* Estimated intelligence quotient \> 85

Exclusion Criteria:

* No biological parent or legal guardian is able to give permission for the minor and agrees to participate in parental assessments
* Prematurity or other perinatal complications that required significant intervention
* History of neurological disorders, including seizure disorders, cerebral palsy, or other conditions requiring neurological or medical care :
* History of head injury:

  * Head trauma more than one year old with loss of consciousness \>30 minutes, OR
  * Had to be hospitalized for head trauma, OR
  * Amnesia \> 24 hours, OR
  * Confusion or loss of orientation \>24 hours, OR
  * A brain scan revealed problems following a head injury, OR
  * Head trauma within the past year with loss of consciousness \>10 minutes. Current or persistent major Axis I psychiatric disorder that may interfere with successful completion of the protocol (e.g., psychosis and bipolar disorder), or substance use disorder.

Current use of medications with significant effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); Attention Deficit Hyperactivity Disorder (ADHD) medications and Selective Serotonin Reuptake Inhibitors (SSRIs) are not excluded as the use of these medications is associated with certain neurodevelopmental disorders and assessment of these individuals will provide useful data to the community Not fluent in French (all youth materials are in French) Uncorrectable visual, hearing, or sensorimotor impairment, as the protocol items may not be valid.

Primary outcomes:
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Create a Normative Database for emotional, behavioral and cognitive performance
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 18 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 18 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
measure: Convergence validity for the O-Kidia battery
timeFrame: 24 months
Secondary outcomes:
measure: Description of participants' characteristics
timeFrame: 24 months
measure: Description of participants' characteristics
timeFrame: 24 months
measure: Description of participants' characteristics
timeFrame: 24 months
measure: Description of participants' characteristics
timeFrame: 24 months
measure: Description of participants' characteristics
timeFrame: 24 months
measure: mobile EEG biomarkers
timeFrame: 24 months
measure: mobile EEG biomarkers
timeFrame: 24 months
measure: mobile EEG biomarkers
timeFrame: 24 months
measure: mobile EEG biomarkers
timeFrame: 24 months
measure: UX/UI feasibility
timeFrame: 12 months
measure: Test-retrests for the O-Games battery
timeFrame: 24 months
Other outcomes:
Locations:
city: Gardanne
country: France
facility: O-Kidia
state: Provence Alpes Cote d'Azur
city: Marseille
country: France
facility: Association la Busserine
state: Provence Alpes Cotes d'Azur
Study officials:
affiliation: O-Kidia
name: Vanessa Douet Vannucci, PhD
role: PRINCIPAL_INVESTIGATOR
References: