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Protocol Details

An Observational Study of the Developing Brain, Impulsivity and Compulsivity

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-HG-0147

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 6 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Glutamate;
Heritability;
NEUROPSYCHIATRIC DISORDER;
Brain Connectivity;
developmental trajectory;
Natural History

Recruitment Keyword(s)

None

Condition(s)

typical development;
Attention Deficit Hyperactivity Disorder;
Conduct Disorder;
Obsessive Compulsive Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

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 have a magnetoencephalography scan. It records brain activity. Participants will sit in a room. A "cone" of magnetic field detectors will be lowered around their head. They will rest and play a game.

Participants may ask family members to join 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.

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Eligibility

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. Male or female, 6 years of age and under 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.

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).

2. Medications that are known to affect glutamate levels (e.g., riluzole, memantine, C-cycloserine).

3. Antipsychotic medication (as these have a major impact on dopamine levels).


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Citations:

Ziegler G, Hauser TU, Moutoussis M, Bullmore ET, Goodyer IM, Fonagy P, Jones PB; NSPN Consortium, Lindenberger U, Dolan RJ. Compulsivity and impulsivity traits linked to attenuated developmental frontostriatal myelination trajectories. Nat Neurosci. 2019 Jun;22(6):992-999. doi: 10.1038/s41593-019-0394-3. Epub 2019 May 13. PMID: 31086316.

Naaijen J, Lythgoe DJ, Amiri H, Buitelaar JK, Glennon JC. Fronto-striatal glutamatergic compounds in compulsive and impulsive syndromes: a review of magnetic resonance spectroscopy studies. Neurosci Biobehav Rev. 2015 May;52:74-88. doi: 10.1016/j.neubiorev.2015.02.009. Epub 2015 Feb 21. PMID: 25712432.

Fineberg NA, Chamberlain SR, Goudriaan AE, Stein DJ, Vanderschuren LJ, Gillan CM, Shekar S, Gorwood PA, Voon V, Morein-Zamir S, Denys D, Sahakian BJ, Moeller FG, Robbins TW, Potenza MN. New developments in human neurocognition: clinical, genetic, and brain imaging correlates of impulsivity and compulsivity. CNS Spectr. 2014 Feb;19(1):69-89. doi: 10.1017/S1092852913000801. PMID: 24512640; PMCID: PMC4113335.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Tonya J. White, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CRC BG RM 4-2352
10 CENTER DR
BETHESDA MD 20892
(301) 402-4000
tonya.white@nih.gov

Wendy S. Sharp, L.C.S.W.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 3B19
10 Center Drive
Bethesda, Maryland 20892
(301) 496-0851
sharpw@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04631042

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