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临床试验/NCT00877942
NCT00877942已完成不适用

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

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
295
试验地点
1
主要终点
Brain volumes on MRI

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
2 Weeks 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

结局指标

主要结局

Brain volumes on MRI

时间窗: 2-4 weeks post birth

次要结局

  • Brain volumes and DTI parameters(2-4 weeks post birth, 1 yr, 2 yr)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Knickmeyer Santelli

Assistant Professor

University of North Carolina, Chapel Hill

研究点 (1)

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