Sex Differences in Early Brain Development; Brain Development in Turner Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rebecca Knickmeyer Santelli, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00877942
First received: April 6, 2009
Last updated: May 1, 2014
Last verified: May 2014

April 6, 2009
May 1, 2014
October 2006
May 2014   (final data collection date for primary outcome measure)
Brain volumes on MRI [ Time Frame: 2-4 weeks post birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00877942 on ClinicalTrials.gov Archive Site
Brain volumes and DTI parameters [ Time Frame: 2-4 weeks post birth, 1 yr, 2 yr ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sex Differences in Early Brain Development; Brain Development in Turner Syndrome
Sex Differences in Early Brain Development; Brain Development in Turner Syndrome

Relative risk for many psychiatric disorders differs dramatically in males and females. Early-onset disorders, such as autism, occur more often in males; other conditions, such as schizophrenia, occur at similar rates in males and females, but the sexes differ in expression. It has been hypothesized that the prevalence and expression of these disorders is related to sex differences in brain development. X-chromosome effects and early exposure to gonadal hormones are strong candidates for a causal role. The aims of the research are (1) to characterize sex differences in brain development from birth to age 2; (2) to test whether brain development is altered in infants with Turner syndrome, a well-defined genetic disorder resulting from the partial or complete loss of one of the sex chromosomes. To address aim 1, high resolution MRI, including diffusion tensor imaging (DTI), will be used to characterize sex differences in brain development from birth to age 2 in a longitudinal cohort of 250 children. To address aim 2, high resolution MRI, including DTI, will be used to compare brain development in 70 infants with Turner syndrome (X monosomy) to matched controls from aim 1. The investigators hypothesize that sex differences in gray and white matter development and in white matter maturation as assessed by DTI will be present during the first 2 years of life and that children with TS will exhibit abnormal gray and white matter development in the neonatal period.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

For participating children with Turner Syndrome, subjects may participate in an optional blood draw for DNA extraction and hormone assays.

Non-Probability Sample

Control subjects are recruited from the Prenatal Diagnostic Clinic at UNC-Chapel Hill, which performs over 12,000 prenatal ultrasound scans a year. Please note that all pregnant women in North Carolina are referred for an ultrasound at gestational age 18 weeks as part of routine prenatal care. Subjects with Turner syndrome are identified through the UNC Turner Syndrome clinic, through advertisements with relevant local and national support groups such as the Turner Syndrome Society, and through genetic counselors and other relevant health professionals throughout the United States.

Turner Syndrome
Not Provided
  • 1
    Typically developing children drawn from the general population
  • 2
    Children with Turner Syndrome
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
295
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • For controls a child must have a normal ultrasound at the 18 week prenatal visit and the absence of major medical or psychiatric conditions in the mother.
  • Children with Turner Syndrome must have diagnosis confirmed by genetic testing.

Exclusion Criteria:

  • For controls - major medical or psychiatric conditions in the mother and major medical problems or congenital conditions in the child.
  • For Turner children - The study is open to all TS karyotypes except those with Y chromosome material.
  • For both groups children with conditions that preclude participating in an MRI scan ( i.e. metal in the body)
Both
up to 2 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00877942
K01MH083045-01, 1K01MH083045-01
No
Rebecca Knickmeyer Santelli, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Principal Investigator: Rebecca C Knickmeyer, Ph.D. University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP