The Effects of Estrogen on Cognition in Girls With Turner Syndrome

March 3, 2008 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Estrogen Effects on Cognition in Girls With Turner Syndrome

The development of the brain in females is a result of a combination of factors. During puberty estrogen plays a role in influencing brain development. Cultural and environmental factors also play a role in the development of the brain.

Female patients with Turner syndrome lack the ability to produce estrogen due to undeveloped ovaries. Therefore, Turner syndrome is the perfect condition to study how estrogen (or the lack of estrogen) influences a person's behavior and thinking.

This study will compare cognitive differences (visual motor skills, visual-spatial, psychosocial behavior, and visual memory) of patients with Turner syndrome to normal patient controls. Researchers will use the Weschler Intelligence Scale for Children-Revised (WISC-R) along with other tests and scales to measure different aspects of the patient's cognitive ability. In addition the study will review patients with Turner syndrome who previously received estrogen replacement as infants and children in a related research study.

Researchers hope to demonstrate that estrogen replacement will improve cognition and behavior in girls with Turner syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Estrogen influences brain development in females at puberty. Environmental and cultural factors interact with the biological effects of estrogen on the brain and consequently on cognition and behavior. Turner syndrome females lack endogenous estrogen as a result of dysgenetic ovaries. Turner syndrome therefore represents a unique, estrogen-deficient model in which to study the biological effects of estrogen on cognition and behavior. The specific aims of this project are to: 1) document further, the cognitive differences between girls with Turner syndrome at ages 5 to adult (less than or equal to age 50) versus age-matched, female controls. 2) to examine the differential effects of continuous estrogen replacement in infancy and in early childhood on cognitive and social function in a unique, previously approved, randomized, double-blind, placebo-controlled, treatment trial (87-CH-0152). Specifically, we hypothesize that estrogen replacement in early childhood will reduce the cognitive deficits of girls with Turner syndrome. In addition, we hypothesize that the degree of socialization ability in these girls will correlate with social-behavioral and social recognition ability. Finally, we hypothesize that earlier (infancy to 8 years) and longer estrogen replacement will result in less impairment of visual-motor ability, visual-spatial ability, socialization ability, and affective competence compared to later (9 to 12 years) estrogen replacement in girls with Turner syndrome.

Children with Turner syndrome and controls will be tested in the Outpatient Departments at the two approved sites of protocol 87-CH-0152; the NIH and Thomas Jefferson University.

Study Type

Interventional

Enrollment

950

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Child Health and Human Development (NICHD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

Patients will include girls and women ages 5-50 yr with the diagnosis of Turner syndrome based on absence of all or part of one of the X chromosomes.

Control subjects must be within +/- 2SD for height and weight and have normal intelligence and educational achievement.

Biological parents (both male and female) of TS subjects may be included in this study, but only to have blood drawn for genetic testing in order to determine the origin of the X-chromosome of their daughters.

EXCLUSION CRITERIA:

Those with severe physical or neurocognitive impairment, preventing accurate completion of the cognitive tasks, will be excluded.

Normal subjects who have qualified for or participated in gifted and talented or remedial education programs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1990

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (ESTIMATE)

November 4, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 900123
  • 90-CH-0123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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