Developing Brain, Impulsivity and Compulsivity (NCT04631042) | Clinical Trial Compass
RecruitingNot Applicable
Developing Brain, Impulsivity and Compulsivity
United States1,100 participantsStarted 2022-09-30
Plain-language summary
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.
Who can participate
Age range
6 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Must be between 6 and 80 years of age.
. Ability of participant to understand and the willingness to sign a written informed consent document.
Exclusion criteria
. 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.)
. Very premature birth (i.e., birth before 32 weeks of gestational age).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring glutamate levels in the brain using MRI spectroscopy in children with ADHD, OCD, autism, and conduct disorder — can you help me understand what role glutamate is thought to play in my child's condition, and why tracking it might matter for their care down the road?
2Since this trial is listed as Phase NA, which suggests it's observational or a brain imaging study rather than a treatment trial, does that mean my child wouldn't be receiving any experimental medication or intervention — just scans and assessments?
3The study mentions looking at heritability of brain glutamate levels, which sounds like it may involve family members — would other people in our family need to participate, and what would that actually involve for us logistically?
4Because this appears to be a research study measuring brain development rather than testing a new therapy, how would taking part compare to simply continuing with my child's current standard treatment — and could participating affect or delay any treatment decisions we need to make now?
5If my child takes part and the MRS scans reveal something unexpected about their glutamate levels or brain development, would we be informed of those findings, and would there be any follow-up support or next steps offered?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glutamate concentration measured using Magnetic Resonance Spectroscopy
Timeframe: Yearly if possible
2
Heritability of cortical glutamate (proportion of variance explained by additive genetic factors).
. 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).
. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).
. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.
. Pregnant women.
. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments.