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Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Children
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), November 2009
First Received: November 3, 1999   Last Updated: December 11, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001246
  Purpose

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 MRIs to assess brain anatomy and function in normal 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, multidimensional impairment syndrome, obsessive compulsive disorder, Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infection (PANDAS), stuttering, 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.


Condition
Autoimmune Disease
Congenital Adrenal Hyperplasia
Healthy
Mental Disorder Diagnosed in Childhood
Neurologic Manifestations

Study Type: Observational
Official Title: Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 6000
Study Start Date: January 1989
Detailed Description:

Driven by the hypotheses 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, we are acquiring brain images in healthy and neuropsychiatrically impaired subjects. To explore gene, brain, behavior relationships in health and illness we are also acquiring DNA along with clinical, behavioral, and cognitive data in singleton and twin populations. Controls and clinical populations are screened and characterized in behavioral, cognitive, and physical domains. Longitudinal brain MRI scans are acquired and analyzed using state-of-the-art image analysis techniques. Data from the project has resulted in seminal papers on Attention-Deficit/Hyperactivity Disorder, Childhood-Onset Schizophrenia, and normal pediatric brain development. The data from the normative project is unique in its longitudinal nature and sample size.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA FOR HEALTHY CONTROLS:

Subjects consenting to participation in the study

-Over 3 years of age with no upper limit for age at time of enrollment.

EXCLUSION CRITERIA FOR HEALTHY CONTROLS:

  • Presence of any psychiatric disorder in the subject, sibling, or other first-degree relative.
  • Current or past use of psychiatric medication.
  • Special service needs in school.
  • Presence or history of medical conditions known to affect cerebral anatomy.
  • Dental braces.
  • Metal in the body or other contraindications for MRI scanning.
  • For females who have reached menarche: Pregnancy or inability or unwillingness to undergo pregnancy testing.

INCLUSION CRITERIA FOR PATIENT POPULATIONS:

  • Male and female subjects over 3 years of age with no upper limit for age at time of enrollment.
  • Currently meet criteria for at least one of the following:

    • DSM-IV (or other approved) criteria for one of the following clinical diagnoses: Multi-Dimensionally Impaired, Obsessive Compulsive Disorder, Childhood Onset Schizophrenia, Turner Syndrome, Autism Spectrum Disorder, Asperger Syndrome, High Functioning Autism, Pervasive Development Disorder
    • Sex chromosome aneuploidy as determined by karyotype (including XXX, XXXX, XXXXX, XXY, XXYY, XXXY, XXXXY, XYY).
    • ICD-10 criteria for Congenital Adrenal Hyperplasia and Cushings Syndrome.
    • ADHD
    • Down's Syndrome
  • Newly enrolled adults and minors once they become adults over age 18 who cannot give consent due to limited capacity may have a surrogate, i.e., a legally responsible representative (LAR), sign the consent. LARs include DPA holders, court-appointed legal guardians, or parents or siblings over 18 years of age. We will consult with the Human Subjects Protection Unit as necessary.

EXCLUSION CRITERIA FOR ALL PATIENT POPULATIONS:

  • Dental braces.
  • Metal in the body or other contraindications for MRI scanning.
  • For females who have reached menarche: Pregnancy or inability or unwillingness to undergo pregnancy testing.
  • Evidence of another medical condition or traumatic event known to affect cerebral anatomy.
  • A known genetic disorder (other than the condition under investigation) that would be expected to significantly impact findings from cognitive testing and/or neuroimaging.

ADDITIONAL INCLUSION CRITERIA FOR ADHD PARTICIPANTS:

  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-defined ADHD. The DSM-IV diagnosis of ADHD will be based on the Parent Diagnostic Interview for Children and Adolescents.
  • Conners' Teacher Hyperactivity rating greater than 2 SD above age- and sex-specific means.

ADDITIONAL EXCLUSION CRITERIA FOR ADHD PARTICIPANTS:

  • A full-scale IQ of less than 80.
  • Birth before 34 weeks of gestation.
  • Other axis I psychiatric disorder requiring treatment with medication at study entry (with the exception of oppositional-defiant disorder).

ADDITIONAL INCLUSION CRITERIA FOR DOWN SYNDROME PARTICIPANTS:

  • Confirmed chromosomal diagnosis of Trisomy 21.
  • Age between 3 years and 17 years, 11 months. This upper age limit was chosen for two reasons. First, the vast majority of studies of the neuroanatomy of Down syndrome have focused on adult populations and the heightened risk for Alzheimer's disease in this group. Thus, additional pediatric studies are needed to understand the early developmental course of the neuroanatomical and neuropsychological phenotype associated with Down syndrome. Second, by excluding participants over the age of majority, issues related to capacity to provide legal consent to participate will be avoided. With these and all pediatric participants, care will be taken to assure that assent is obtained and periodic checks will be completed throughout testing to determine continued willingness to complete all tests and procedures.

ADDITIONAL INCLUSION CRITERIA FOR PARTICIPANTS WITH AUTISM SPECTRUM DISORDERS:

  • Meeting DSM-IV criteria for one of the pervasive developmental disorders (i.e., autistic disorder, Asperger disorder, or pervasive developmental disorder-not otherwise specified).
  • Having a minimum IQ of 70.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001246

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 890006, 89-M-0006
Study First Received: November 3, 1999
Last Updated: December 11, 2009
ClinicalTrials.gov Identifier: NCT00001246     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Autism
Dyslexia
Magnetic Resonance Imaging
Attention Deficit Hyperactivity Disorder
Twin
Childhood Onset Schizophrenia
Obsessive Compulsive Disorder
Sydenham's Chorea
Tourette's Disorder
Klinefelter's Syndrome
Congenital Adrenal Hyperplasia
Twin

Additional relevant MeSH terms:
Metabolic Diseases
Autoimmune Diseases
Disease
Immune System Diseases
Gonadal Disorders
Nervous System Diseases
Adrenal Gland Diseases
Adrenogenital Syndrome
Endocrine System Diseases
Sex Differentiation Disorders
Adrenocortical Hyperfunction
Signs and Symptoms
Metabolism, Inborn Errors
Hyperplasia
Pathologic Processes
Genetic Diseases, Inborn
Mental Disorders
Mental Disorders Diagnosed in Childhood
Adrenal Hyperplasia, Congenital
Neurologic Manifestations
Steroid Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on February 08, 2010