Status:

RECRUITING

Pediatric Neuroimaging

Lead Sponsor:

National Institute on Aging (NIA)

Conditions:

Neurogimaging

Eligibility:

All Genders

9-14 years

Brief Summary

Background: Puberty is a normal part of life. Many big changes occur in all parts of the body as a child matures into an adult. Researchers in this study want to find out more about how the brain cha...

Detailed Description

Study Description: We aim to establish the feasibility of recruitment of children aged 9 to 14 years old to obtain high-quality neuroimaging of white matter determinants employing the Bayesian Monte ...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, 9 to 14 years of age.
  • In good general health
  • Ability of parent/guardian to understand and the willingness to sign a written informed consent document.
  • Ability of participant to participate in the assent process and willingness to sign a written informed assent document.
  • EXCLUSION CRITERIA:
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Any known brain abnormalities (e.g. tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral micro or macro-structural integrity (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).
  • History neurodevelopmental delay or disorder, learning disability, intellectual disability (formerly referred to as mental retardation), autism spectrum disorders, and attention deficit/hyperactivity disorder (ADHD)), as evaluated history, physical and by the SDQ, and if indicated, the KSADS
  • History of psychiatric disorder as evaluated by history and the SDQ, and if indicated, the KSADS.
  • History of prematurity (\< 32 weeks gestational age).
  • History of endocrine abnormalities, including diagnosed disorders of thyroid, growth, and precocious or delayed puberty
  • History of major medical conditions or chronic medical conditions. Examples include neurological disorders, medical or genetic conditions with associated neurological manifestations, malnutrition, conditions raising risk of micronutrient or macronutrient deficiencies (e.g. inflammatory bowel disease), untreated chronic anemia, cardiovascular disease, significant lung disease (e.g. bronchiectasis), significant liver disease, significant kidney disease, significant autoimmune condition, and chronic infections (e.g. HIV, hepatitis B).
  • Pregnancy.
  • Not eligible to have an MRI as per the MRI eligibility form and the safety standards of the NIA 3T MRI center.
  • Presence of hardware (e.g. orthodontic braces) that may interfere with MRI data quality.
  • Any other condition which in the investigator s opinion may adversely affect the subject s ability to complete the study or its measures or which may pose significant risk to the subject.

Exclusion

    Key Trial Info

    Start Date :

    April 21 2025

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2026

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT06912724

    Start Date

    April 21 2025

    End Date

    June 1 2026

    Last Update

    December 23 2025

    Active Locations (1)

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    National Institute of Aging, Clinical Research Unit

    Baltimore, Maryland, United States, 21224