- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00336726
Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation With Cognitive Dysfunction and Repair
March 23, 2011 updated by: Denver Research Institute
Traumatic Brain Injury (TBI) is a neurologic disorder cuased by physical trauma to the brain.
Neuroendocrine abnormalities in these patients have been reported, including central hypogonadism within hours of the insult and eventual recovery of the hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline.
This pilot study will measure hormonal level of neuroendocine function at the time of TBI and various time points during recovery.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
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
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Male subjects having had a recent traumatic brain injury
Description
Inclusion Criteria:
- Male subjects having had a recent traumatic brain injury.
Exclusion Criteria:
- Currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.
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
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margaret E Wierman, MD, Dept. of Veterans Affairs/University of Colorado HSC
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 Registration Dates
First Submitted
June 13, 2006
First Submitted That Met QC Criteria
June 13, 2006
First Posted (Estimate)
June 14, 2006
Study Record Updates
Last Update Posted (Estimate)
March 24, 2011
Last Update Submitted That Met QC Criteria
March 23, 2011
Last Verified
December 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR-735
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.