Sex Differences in Early Brain Development; Brain Development in Turner Syndrome
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Purpose
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.
| Condition |
|---|
|
Turner Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Sex Differences in Early Brain Development; Brain Development in Turner Syndrome |
- Brain volumes on MRI [ Time Frame: 2-4 weeks post birth ] [ Designated as safety issue: No ]
- Brain volumes and DTI parameters [ Time Frame: 2-4 weeks post birth, 1 yr, 2 yr ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
For participating children with Turner Syndrome, subjects may participate in an optional blood draw for DNA extraction and hormone assays.
| Estimated Enrollment: | 320 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Typically developing children drawn from the general population
|
|
2
Children with Turner Syndrome
|
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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)
Contacts and Locations| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Rebecca C Knickmeyer, Ph.D. | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Rebecca Knickmeyer, Assistant Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00877942 History of Changes |
| Other Study ID Numbers: | K01MH083045-01, 1K01MH083045-01 |
| Study First Received: | April 6, 2009 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |
Congenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Genetic Diseases, Inborn Gonadal Disorders Endocrine System Diseases Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013