NCT05577533

Digital Epidemiology Study on Brain Functioning

Digital Epidemiology Study on Brain Functioning in Children Aged 7 to 12 Years

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 736 (estimated)
• Sponsor: O-Kidia · Industry
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Child Development
• Child Development Disorder

Interventions

Type	Name	Description
BEHAVIORAL	O-Kidia game battery	Children will be playing on a series of games with a touch screen tablet while video and digit trajectories data will be collected from this mobile device to analyze eye-, face-, sound-recognition.
BEHAVIORAL	O-Brain	Electrical recordings and measurements - A mobile EEG headset will be used during the visit - 30 min

Timeline

• Start date: 2023-03-21
• Primary completion: 2024-07-01
• Completion: 2024-09-30
• First posted: 2022-10-13
• Last updated: 2023-10-19

Locations

2 sites across 1 country: France