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COgnitive Dynamics in Early Childhood (CODEC)

R

Radboud University Medical Center

Status

Enrolling

Conditions

Cognitive Change

Study type

Observational

Funder types

Other

Identifiers

NCT06330090
NL84688.091.23
101040534 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:

  1. How does cognitive variability differ between individuals?
  2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
  3. What are the long-term consequences and outcomes associated with differences in cognitive variability?

Enrollment

600 estimated patients

Sex

All

Ages

7 to 13 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • In order to be eligible to participate in the behavioural arm of this study, a subject must meet all of the following criteria:

    • Between the ages of 7 and 10 years at the moment of the first assessment. In order to be eligible to participate in the imaging arm of this study, a subject must meet all of the following criteria:
    • Between the ages of 8 and 10 years at the moment of the first assessment.

Exclusion criteria

  • A potential subject will be excluded from participation in the study if the participant indicates not understanding the instructions of the behavioural tasks due to a language barrier. In the imaging arm of the study, a potential subject who meets any of the following criteria will further be excluded from participation in the imaging arm of the study:

    • History of neurological or psychiatric illness.
    • History of using psychotropic medications.
    • Contraindications for MRI.
    • Metal parts that cannot be removed, are present in or on upper body, e.g. plates, screws, aneurysm clips, metal splinters, piercings or medical plasters. (exception: dental fillings, crowns, a metal wire behind the teeth, tattoos and contraceptive coils).
    • Body containing metal fragments, in particular in the eye, e.g., caused by injuries when working with metal.
    • History of brain surgery.
    • Active implant(s) (e.g. pacemaker, neurostimulator, insulin pump, ossicle prosthesis)
    • Using a medical plaster that cannot or may not be taken off (e.g. nicotine plaster)

Trial design

600 participants in 1 patient group

Design
Description:
Behavioural or behavioural with imaging

Trial contacts and locations

1

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Central trial contact

Ilse Coolen; Rogier Kievit

Data sourced from clinicaltrials.gov

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