NCT00001253

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1990

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1990

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Gonadal DysgenesisTurner's Syndrome

Keywords

Turner's SyndromeEstrogenEthinyl estradiolLearningOvarian dysgenesis

Interventions

cognitive tests and scalesBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Palmer CG, Reichmann A. Chromosomal and clinical findings in 110 females with Turner syndrome. Hum Genet. 1976 Dec 29;35(1):35-49. doi: 10.1007/BF00295617.

    PMID: 1002163BACKGROUND

  • Singh RP, Carr DH. The anatomy and histology of XO human embryos and fetuses. Anat Rec. 1966 Jul;155(3):369-83. doi: 10.1002/ar.1091550309. No abstract available.

    PMID: 5956901BACKGROUND

  • Park E, Bailey JD, Cowell CA. Growth and maturation of patients with Turner's syndrome. Pediatr Res. 1983 Jan;17(1):1-7. doi: 10.1203/00006450-198301000-00001. No abstract available.

    PMID: 6835711BACKGROUND

MeSH Terms

Conditions

Gonadal DysgenesisTurner Syndrome

Interventions

Neuropsychological TestsWeights and Measures

Condition Hierarchy (Ancestors)

Disorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesSex Chromosome Disorders of Sex DevelopmentHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesSex Chromosome DisordersChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

May 1, 1990

Study Completion

March 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-03

Locations

US(1)