Understanding brain development and behaviors like impulsivity and compulsivity

An Observational Study of the Developing Brain, Impulsivity and Compulsivity

This study looks at how brain development affects impulsive and compulsive behaviors in people aged 6 to 80 to see if there are links between genetics and brain features.

Quick facts

• Study type: Observational
• Enrollment: 1100 (estimated)
• Ages: 6 Years to 80 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT04631042 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between brain development and behaviors associated with impulsivity and compulsivity in individuals aged 6 to 80. Researchers will assess participants through medical history reviews, surveys on mental and behavioral development, and cognitive tests. Additionally, blood or saliva samples will be collected for genetic analysis to investigate the heritability of these behaviors and their association with brain features such as cortical glutamate levels. The study employs a longitudinal design to track developmental changes over time.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 6 to 80 who are willing to participate and can provide informed consent.

Not a fit: Patients with cognitive impairments that prevent them from understanding or participating in the study may not benefit from this research.

Why it matters

Potential benefit: If successful, this study could provide insights into the genetic and neurobiological underpinnings of impulsivity and compulsivity, potentially leading to better-targeted interventions for related disorders.

How similar studies have performed: While the study's specific approach is novel, previous research has indicated that understanding the genetic and neurobiological factors of impulsivity and compulsivity can lead to meaningful insights in neuropsychiatric disorders.

Eligibility criteria

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following 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.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

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.

Additional exclusion criteria for optional MRI procedure:

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).

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Tonya J White, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Tonya J White, M.D.

Conditions: Typical Development, Obsessive Compulsive Disorder, Conduct Disorder, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Neurodevelopmental disorder, Twin, Natural History