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Clinical Trials/NCT00001246
NCT00001246
Active, Not Recruiting
N/A

Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers

National Institute of Mental Health (NIMH)1 site in 1 country4,274 target enrollmentJune 19, 1990

Overview

Phase
N/A
Intervention
1
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
National Institute of Mental Health (NIMH)
Enrollment
4274
Locations
1
Primary Endpoint
Volumetric MRI Data
Status
Active, Not Recruiting
Last Updated
yesterday

Overview

Brief Summary

Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to create a picture. MRI use as the name implies, magnetism to create pictures with excellent anatomical resolution. Functional MRIs are diagnostic tests that allow doctors to not only view anatomy, but physiology and function. It is for these reasons that MRIs are excellent methods for studying the brain.

In this study, researchers will use MRI to assess brain anatomy and function in X and Y chromosome variation, healthy volunteers, and patients with a variety of childhood onset psychiatric disorders. The disorders include attention deficit disorder, autism, congenital adrenal hyperplasia, childhood-onset schizophrenia, dyslexia, obsessive compulsive disorder, Sydenham's chorea, and Tourette's syndrome.

Results of the MRIs showing the anatomy of the brain and brain function will be compared across age, sex (gender), and diagnostic groups. Correlations between brain and behavioral measures will be examined for normal and clinical populations....

Detailed Description

Study Description: This natural history protocol will have participants come to the NIH for brain imaging, psychological/psychiatric testing, and genetic characterization. Our core hypotheses are that many of the most severe neuropsychiatric disorders of childhood onset are associated with deviations from the path of normal brain development, the neuroanatomical substrates of which can be detected by magnetic resonance imaging. Objectives: Primary Objectives: The long-term objectives of the protocol are to (1) map the neuroanatomic and neurophysiological trajectories of brain development; and (2) discern the influences, for good or ill, on those trajectories from demographic clinical, genetic, and environmental factors. Approximately half of the participants in our sample are typically developing. Clinical populations in our sample include participants with a variety of brain-based disorders, such as Autism, Attention-Deficit/Hyperactivity Disorder, Childhood Onset Schizophrenia, Dyslexia, Sydenham s Chorea, and Tourette s Syndrome. Secondary Objectives: To characterize the relationships among measures of behavior and cognition as well as amongst multimodal measures of brain organization. Endpoints: Primary Endpoint: T1-weighted structural neuroimaging data which enable us to characterize how a range of anatomical brain phenotypes vary as a function of age, sex, behavioral/cognitive traits, diagnostic status and genotype. Secondary Endpoints: Data analyses also consider how these factors relate to other outcomes of interest including; gene expression levels, functional metrics from in vivo neuroimaging, and questionnaire/interview-based assessment of clinical features.

Registry
clinicaltrials.gov
Start Date
June 19, 1990
End Date
TBD
Last Updated
yesterday
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • INCLUSION CRITERIA:
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Inclusion criteria for healthy controls
  • Participants consenting to participation in the study
  • Over 3 years of age with no upper limit for age at time of enrollment.
  • Inclusion criteria for MRI scanner calibration project:
  • Participants will meet protocol criteria for adult healthy volunteers.
  • Inclusion criteria for affected participant populations:
  • Male and female participants over 3 years of age with no upper limit for age (with the exception of the Down syndrome group - see below). Currently meet criteria for at least one of the following:
  • DSM-IV (or other approved) criteria for one of the following clinical diagnoses: Obsessive Compulsive Disorder, Childhood Onset Schizophrenia, Turner Syndrome, Autism Spectrum Disorder, Asperger Syndrome, High Functioning Autism, Pervasive Development Disorder

Exclusion Criteria

  • NIMH staff and their immediate family are excluded from participation.
  • Exclusion criteria for healthy controls:
  • Presence of severe psychiatric disorder (as diagnosed prior to participant study enrollment) in the participant. For these purposes, exclusionary severe psychiatric disorder includes schizophrenia and bipolar affective disorder.
  • Presence or history of medical conditions known to affect cerebral anatomy.
  • Dental braces.
  • Contraindications for MRI scanning according to the NMR Center MRI Safety Screening Questionnaire and guidelines.
  • For females who have reached menarche: Pregnancy or inability or unwillingness to undergo pregnancy testing.
  • Exclusion criteria for all affected participant populations, including parents and siblings of the affected participants:
  • Dental braces.
  • Contraindications for MRI scanning according to the NMR Center MRI Safety Screening Questionnaire and guidelines.

Arms & Interventions

1

Our studies include data from typically developing youth, and individuals with a range of psychiatric presentations from behaviorally-defined (e.g. Childhood-Onset Schizophrenia, Autism Spectrum Disorder) as well as genetically-defined (e.g. Sex Chromosome Aneuploidy) groups. Participants span a wide age range (from 3 years of age upwards).

Outcomes

Primary Outcomes

Volumetric MRI Data

Time Frame: Ongoing

Volumetric MRI Data

Secondary Outcomes

  • Cognitive data(Ongoing)

Study Sites (1)

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