Understanding brain changes during puberty in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how the brain changes in healthy children aged 9 to 14 years before, during, and after puberty. Participants will undergo two clinic visits, where they will complete physical exams, mental health questionnaires, and mock MRI scans to familiarize them with the process. The study will utilize advanced neuroimaging techniques to assess white matter changes and explore the relationship between pubertal status, body composition, and neuroimaging parameters. The data collected will help inform future longitudinal studies on normative cerebral microstructural changes in this age group.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institute of Aging, Clinical Research Unit
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Tina Gupta, M.D. — National Institute on Aging (NIA)
• Study coordinator: Tina Gupta, M.D.
• Email: tina.gupta@nih.gov
• Phone: (301) 451-0481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.