Early Brain Development in Twins

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01409746
First received: April 6, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to study the role of genes and environment in early brain development using a twin approach. The investigators will use magnetic resonance imaging (MRI) to study brain structure and it's relationship to cognitive development. Specifically, the investigators will study cortical gray and white matter volumes, volumes of subcortical structures and cerebellum, as well as diffusion properties in major white matter tracts using DTI tractography.


Condition
Twin Brain Development

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Brain Development in Twins

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Brain Gray Matter Volume [ Time Frame: Change in heritability from birth to age 6 years ] [ Designated as safety issue: No ]
    Will assess gray matter volume with MRI and use structural equation modeling to determine relative contributions of genes and environment to variation of gray matter volumes.

  • Brain white matter tract integrity [ Time Frame: Change in heritability from birth to age 6 years ] [ Designated as safety issue: No ]
    Will assess white matter tract development and integrity using diffusion tensor imaging and will determine relative contributions of genes and environment ot this using twin methodology.


Secondary Outcome Measures:
  • Mullen composite Score [ Time Frame: 1,2,4,6 years ] [ Designated as safety issue: No ]
    Will assess genetic and environmental contributions to early cognitive development using a twin methodology


Biospecimen Retention:   Samples With DNA

buccal swabs; MRIs, ultrasounds


Estimated Enrollment: 600
Study Start Date: April 2004
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
twins
twin pairs

Detailed Description:

Twin studies have been critical in determining the contributions of genetic and environmental factors to normal brain structure and for understanding abnormalities of brain development that underlie neurodevelopmental and neuropsychiatric disorders. In adults and older children, twin studies indicate that genes play a significant role in the variability of global brain volumes, including total brain, total gray and total white matter volumes. Other than this current study, there have been no studies of twin brain development in early childhood, the period of brain development implicated in the pathogenesis of many psychiatric disorders. In the first funding cycle of this grant, the investigators used prenatal ultrasound and neonatal MRI to study discordance of early brain development, and to determine genetic and environmental contributions to neonatal brain structure. The investigators have and have developed a unique and valuable cohort of twins, having recruited and scanned over 100 twin pairs. The investigators found that discordance of prenatal brain size in MZ twins is similar to that in DZ twins, but that by 1 month after birth, discordance of overall brain volume in MZ twins is already less than in DZ twins. Contrary to our original hypothesis, statistical modeling of neonatal MRI brain volumes in our twin cohort indicates that global tissue volumes are highly heritable, similar to that observed in older children and adults. Therefore, it appears that genetic programs act very early in postnatal brain development to determine global tissue volumes. Interestingly, preliminary longitudinal mapping of correlations in gray matter density indicate correlations decrease in the first year of life, perhaps as the result of rapid brain growth in the first years of life. The investigators also found that while global white matter volumes are highly heritable, diffusion tensor properties of specific white matter tracts are not. In the next funding cycle, the investigators propose to continue enlarging this unique cohort and to follow them through age 6 years with structural MRI, diffusion tensor imaging (DTI), and developmental assessments to determine how genetic and environmental factors contribute to brain development in the first years of life.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

medical center and community sample

Criteria

Inclusion Criteria:

  • twins

Exclusion Criteria:

  • major medical, obstetrical or neurological complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409746

Contacts
Contact: John H Gilmore, MD 919-966-6971 jgilmore@med.unc.edu

Locations
United States, North Carolina
UNC Department of Psychiatry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: John Gilmore, MD    919-966-6971    jgilmore@med.unc.edu   
Principal Investigator: John H Gilmore, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: John H Gilmore, MD University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01409746     History of Changes
Other Study ID Numbers: 03-0989, R01MH070890-05
Study First Received: April 6, 2009
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
twin
brain development
MRI

ClinicalTrials.gov processed this record on August 26, 2014