RECRUITING

Developing Brain, Impulsivity and Compulsivity

Conditions

Typical Development Obsessive Compulsive Disorder Conduct Disorder Attention Deficit Hyperactivity Disorder Autism Spectrum Disorder Neurodevelopmental disorder Twin Natural History Heritability Glutamate developmental trajectory Brain Connectivity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic \& brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6 - 80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.

Official Title

An Observational Study of the Developing Brain, Impulsivity and Compulsivity

Quick Facts

Study Start:2022-09-30

Study Completion:2031-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04631042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Must be between 6 and 80 years of age. 3. Ability of participant to understand and the willingness to sign a written informed consent document.	1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.) 2. Very premature birth (i.e., birth before 32 weeks of gestational age). 3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more). 4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified). 5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study. 6. Pregnant women. 7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments. 1. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).

Inclusion Criteria

Exclusion Criteria

1. Stated willingness to comply with all study procedures and availability for the duration of the study.
2. Must be between 6 and 80 years of age.
3. Ability of participant to understand and the willingness to sign a written informed consent document.

1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)
2. Very premature birth (i.e., birth before 32 weeks of gestational age).
3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).
4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).
5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.
6. Pregnant women.
7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments.
1. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).

Contacts and Locations

Study Contact

Tonya J White, M.D.

CONTACT

(301) 496-5192

tonya.white@nih.gov

Principal Investigator

Tonya J White, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

Tonya J White, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30

Study Completion Date2031-12-31

Study Record Updates

Study Start Date2022-09-30

Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

Neurodevelopmental disorder
Twin
Natural History
Heritability
Glutamate
developmental trajectory
Brain Connectivity

Additional Relevant MeSH Terms

Typical Development
Obsessive Compulsive Disorder
Conduct Disorder
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder