Digital Epidemiology Study on Brain Functioning (EPIDIA4Kids)

O-Kidia

Status: Enrolling

Conditions: Child Development; Child Development Disorder

Treatments: Behavioral: O-Kidia game battery; Behavioral: O-Brain

Study type: Interventional

Funder types: Industry

Identifiers

NCT05577533

2022-002949-17 (EudraCT Number)

2022-A00766-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 736 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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736 participants in 1 patient group

O-Kidia battery

Other group

Description:

A one-time visit will be performed in children aged 7 to 12 years old as follow : Children will be playing on a series of games with a touch screen tablet while video, EEGs and digit trajectories data will be collected from this mobile device 1. Video recording of the participants during the tablet testing via the intrinsic camera - 30 min 2. Assessments - Paper and tablet psychometric tests will be used during the administrations, 1h45 3. Child health questionnaires - Questionnaires will be completed by children and parents during the visit, 20 min for each

Treatment:

Behavioral: O-Brain

Behavioral: O-Kidia game battery