Traumatic Brain InjuryNCT00336726
Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation With Cognitive Dysfunction and Repair
An observational study of Traumatic Brain Injury, run by Denver Research Institute.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male subjects having had a recent traumatic brain injury
Who may be able to join
- Male subjects having had a recent traumatic brain injury.
Who cannot join
- Currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.
About this study
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.
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Denver Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Margaret E Wierman, MD, Principal investigator, Dept. of Veterans Affairs/University of Colorado HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336726
- Sponsor's protocol ID
- GR-735
- Status last verified
- Dec 2004
- First submitted
- 13 Jun 2006
- Last updated
- 24 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation With Cognitive Dysfunction and Repair
- ClinicalTrials.gov ID
- NCT00336726
- Acronym / sponsor ID
- GR-735
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Denver Research InstituteUniversity, hospital or other
- First posted
- 14 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male subjects having had a recent traumatic brain injury
Key inclusion criteria (1 listed)
- Male subjects having had a recent traumatic brain injury.
Key exclusion criteria (1 listed)
- Currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret E Wierman, MD principal investigator
Dept. of Veterans Affairs/University of Colorado HSC
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Denver Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2011.