Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001253
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
The Effects of Estrogen on Cognition in Girls With Turner Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Estrogen Effects on Cognition in Girls With Turner Syndrome
Status:
COMPLETED
Status Verified Date:
2004-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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 patients 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
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 persons 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 patients 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90-CH-0123 | None | None | None |