NeurogimagingNCT06912724
Pediatric Neuroimaging
An observational study of Neurogimaging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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 changes during puberty. Objective: To study changes that occur in the brain before, during, and after puberty. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogimaging
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
Tina Gupta, M.D., 301-451-0481, tina.gupta@nih.gov
About this study
Official title: A Cross-Sectional Observational Feasibility Pilot Study in Pediatric Neuroimaging: Quantifying White Matter Microstructural Changes in Adolescents With Multidimensional Assessment of Pubertal Stage
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.
Read more
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.
Read the 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 Carlo analysis of multicomponent driven equilibrium single-component observation of T1 and T2 (BMC-mcDESPOT) and constrained neurite orientation dispersion and density imaging (C-NODDI) Magnetic Resonance Imaging (MRI) techniques with a cross-sectional observational pilot study. We additionally aim to establish the feasibility of multidimensional assessment of pubertal status and body composition as they relate to brain white matter. Data from this pilot study would inform the design of our intended future longitudinal investigations gathering reference data descriptive of normative cerebral microstructural changes in a healthy young population.
Objectives:
The primary objective is to demonstrate feasibility of obtaining highquality BMC-mcDESPOT and C-NODDI MRI data from participants between 9 and 14 years old.
The main exploratory objective is to demonstrate the feasibility of completing multidimensional assessments of pubertal status and body composition of participants between 9 and 14 years old to be related to the neuroimaging.
Additional exploratory objectives include investigation of associations of neuroimaging parameters with proteomic and metabolomic biomarkers. We will explore the feasibility of Magnetic Resonance Spectroscopy in this cohort. Biomarkers would include markers for brain cell integrity (mainly oligodendrocytes, but also neurons and other glia) in the soluble phase of plasma and associated with plasma Extracellular Vesicles (EVs), to determine the value of including such parameters in any future longitudinal study.
Endpoints:
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.
The main exploratory endpoint is to complete multidimensional assessments of pubertal status and body composition of up to 30 male and up to 30 female participants between ages 9 and 14 years old.
Additional exploratory endpoints are high-quality MRS images and acquisition of proteomic and metabolomic biomarkers for brain cell integrity in the soluble phase of plasma and plasma EVs.
- Conditions
- Neurogimaging
- Keywords
- Pediatric Neuroimaging Pubertal Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Male and female ages 9-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start21 Apr 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurogimagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tina Gupta, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912724
- Sponsor's protocol ID
- 10002396
- Other IDs
- 002396-AG
- Status last verified
- 19 Dec 2025
- First submitted
- 4 Apr 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Observational Feasibility Pilot Study in Pediatric Neuroimaging: Quantifying White Matter Microstructural Changes in Adolescents With Multidimensional Assessment of Pubertal Stage
- ClinicalTrials.gov ID
- NCT06912724
- Acronym / sponsor ID
- 10002396
- Conditions
- Neurogimaging
- Keywords
- Pediatric Neuroimaging Pubertal Adolescents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Carlo analysis of multicomponent driven equilibrium single-component observation of T1 and T2 (BMC-mcDESPOT) and constrained neurite orientation dispersion and density imaging (C-NODDI) Magnetic Resonance Imaging (MRI) techniques with a cross-sectional observational pilot study. We additionally aim to establish the feasibility of multidimensional assessment of pubertal status and body composition as they relate to brain white matter. Data from this pilot study would inform the design of our intended future longitudinal investigations gathering reference data descriptive of normative cerebral microstructural changes in a healthy young population.
Objectives:
The primary objective is to demonstrate feasibility of obtaining highquality BMC-mcDESPOT and C-NODDI MRI data from participants between 9 and 14 years old.
The main exploratory objective is to demonstrate the feasibility of completing multidimensional assessments of pubertal status and body composition of participants between 9 and 14 years old to be related to the neuroimaging.
Additional exploratory objectives include investigation of associations of neuroimaging parameters with proteomic and metabolomic biomarkers. We will explore the feasibility of Magnetic Resonance Spectroscopy in this cohort. Biomarkers would include markers for brain cell integrity (mainly oligodendrocytes, but also neurons and other glia) in the soluble phase of plasma and associated with plasma Extracellular Vesicles (EVs), to determine the value of including such parameters in any future longitudinal study.
Endpoints:
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.
The main exploratory endpoint is to complete multidimensional assessments of pubertal status and body composition of up to 30 male and up to 30 female participants between ages 9 and 14 years old.
Additional exploratory endpoints are high-quality MRS images and acquisition of proteomic and metabolomic biomarkers for brain cell integrity in the soluble phase of plasma and plasma EVs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Male and female ages 9-14 |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 year of recruitment
Number of participants with high-quality BMC-mcDESPOT and C-NODDI MRI data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Gupta, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogimaging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Gupta, M.D. ((301) 451-0481, tina.gupta@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.