Pediatric Neuroimaging
ConditionNeurogimaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-14
SponsorNational Institute on Aging (NIA)
About this trial
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 changes during puberty.
Objective:
To study changes that occur in the brain before, during, and after puberty.
Eligibility:
Healthy children aged 9 to 14 years.
Design:
Participants will have 2 clinic visits. Each visit will last up to 4 hours.
In the first visit, participants will be screened:
They will have a physical exam with blood tests.
They will complete a mental health questionnaire on a computer.
They will undergo a mock magnetic resonance imaging (MRI) scan. Participants will be made comfortable as they lie on the table and slide into the big tube. They will learn what it feels and sounds like to lie still inside a real MRI.
At the second visit, participants will have more tests:
They will have a physical exam with blood tests. This time the doctor will check for their stage of puberty. The doctor will look at and touch their genitals and breasts.
They will have a real MRI exam.
An x-ray will be taken of their hand and wrist. This will show how their bones are maturing.
They will have a DEXA scan. They will lie on a table while a machine uses x-rays to measure the makeup of their bodies, including bone, muscle, and fat.
They will have a 3D body scan. They will wear tight clothes and a shower cap. They will stand on a platform while sensors take pictures of their body.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
We aim to recruit up to 80 participants between the ages of 9 and 14 years old over a 1-year period with the goal of completion of all study activities by up to 30 male and up to 30 female participants. Recruitment will occur primarily in the Baltimore, Maryland area, as well as the District of Columbia and Virginia areas.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Healthy Volunteers
Trial outcomes
Primary outcomes
1
The primary endpoint is to obtain high-quality BMC-mcDESPOT and C-NODDI MRI data from up to 30 female and up to 30 male participants between 9 and 14 years old.
Number of participants with high-quality BMC-mcDESPOT and C-NODDI MRI data
Time frame
1 year of recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov