Clinical Trial: Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome

Brief Summary: The purpose of this research study is to learn about brain development in very young girls with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain development.

Detailed Summary:

Studies in older children and adults have found that IQ (intelligence quotient) in individuals with Turner syndrome (TS) and the general population are similar. However, many individuals with TS have a nonverbal learning disability which may cause problems with imagining and working with objects in space (for example: building blocks, working puzzles, copying designs, driving a car) as well as problems in planning, paying attention, and getting along with people their own age. Studies of brain structure have found changes in the size and function of specific areas of the brain that are involved in these nonverbal processes. However, there are no data published on brain structure or function in girls with Turner Syndrome in the first few years of life when brains are learning and growing most rapidly.

In a recent study, very young, short girls with Turner Syndrome (TS)(averaging 2 years in age) were treated with Growth Hormone (GH) and almost reached an average height after 2 years. The risks of GH for the young girls in that study appeared to be the same as those for older girls. Therefore, it is now recommended that GH therapy be considered as soon as a child with TS has growth failure. Growth failure often occurs during infancy; therefore, more children with TS are now receiving GH therapy as young as 12 months of age. In this study, the investigators wish to start understanding what effect GH has on learning and brain growth when given between the ages of 12 and 24 months. In this study, the girls with TS will have developmental studies, a physical examination, magnetic resonance imaging (MRI), and blood drawn at one and two years of age. Some of the girls in this study will receive GH from 12 until 24 months of life, while others will not. Brain growth and development will be compared between those who have been treated with GH and those who have not. This is a pilot
Sponsor: Rebecca Knickmeyer Santelli, PhD

Current Primary Outcome: Total Brain Volume [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

Percent change in total brain volume as determined by magnetic resonance imaging (MRI)


Original Primary Outcome: Total Brain Volume [ Time Frame: 12 and 24 months of age ]

Percent change in total brain volume as determined by magnetic resonance imaging (MRI)


Current Secondary Outcome:

  • Volume of Brain Lobes (Occipital) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of occipital lobes as determined by MRI.
  • White Matter Tracts (SLF) [ Time Frame: Change in FA from 12 months of age scan in 24 months of age scan ]
    Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus
  • Volume of Brain Lobes (Central) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.
  • Volume of Brain Lobes (Frontal) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of frontal lobes as determined by MRI.
  • Volume of Brain Lobes (Temporal) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of temporal lobes as determined by MRI.
  • Volume of Brain Lobes (Parietal) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of parietal lobes as determined by MRI.
  • Volume of Brain Lobes (Limbic) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of parietal lobes as determined by MRI.
  • Volume of Brain Lobes (Insular Cortex) [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]
    Percent change in volumes of parietal lobes as determined by MRI.


Original Secondary Outcome:

  • Volume of brain lobes [ Time Frame: 12 and 24 months of age ]
    Percent change in volumes of prefrontal, frontal, temporal, parietal, and occipital lobes as determined by MRI.
  • White matter tracts [ Time Frame: 12 months and 24 months ]
    Change in the fractional anisotropy of white matter tracts using Diffusion Tensor Imaging (DTI)


Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: June 2, 2011
Date Started: May 2010
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017