A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01171131
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-28
• Primary Completion: 2016-03-03
• Study Completion: 2016-03-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proteomic analysis of plasma	average of 6 months post injury	The aim is to identify biomarkers in the blood of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.

Secondary Outcome Measures

Name	Time	Method
Proteomic analysis of saliva	average of 6 months post injury	The aim is to identify biomarkers in the saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.

Trial Locations

Locations (1)

TIRR; 🇺🇸 Houston, Texas, United States