Neuroendocrine Dysfunction in Traumatic Brain Injury: Cor... | NCT00336726

Studies
Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation With Cognitive Dysfunction and Repair

NCT00336726

Sponsor

Denver Research Institute

Status

Terminated

Last Update Posted

Mar 24, 2011Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2004

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 13, 2006

First Submission Date that Met QC Criteria

Jun 13, 2006

First Posted Date

Jun 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2011

Last Update Posted Date

Mar 24, 2011Estimated

Description Module

Brief 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 to baseline. This pilot study will measure hormonal level of neuroendocine function at the time of TBI and various time points during recovery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Male subjects having had a recent traumatic brain injury

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margaret E Wierman, MD	Dept. of Veterans Affairs/University of Colorado HSC	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided