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

A Pilot Study to Identify Biomarkers Associated With Chronic TBI

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Blood/saliva sampling

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

TIRR Clinics

Description

Chronic TBI patients:

Inclusion Criteria

Have a history of head trauma manifesting in one or more of the following:

• Loss of consciousness
• Post-traumatic amnesia
• Focal neurologic deficits, seizure
• Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
• Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.)

Exclusion Criteria

Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Healthy volunteers:

Inclusion Criteria

• No significant medical history
• Take no medications (other than birth control pills)
• Fever free
• No history of head trauma or recent injury/infection
• No history of neurological or psychiatric disorders or alcohol or drug dependency.

Exclusion Criteria

• Inability to provide informed consent
• age/gender match not available in TBI cohort

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic TBI Patients - Non-penetrating; Chronic TBI patients should have a history of head trauma manifesting in one or more of the following: Loss of consciousness; Post-traumatic amnesia; Focal neurologic deficits, seizure; Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance); Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).	Other: Blood/saliva sampling; one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
Chronic TBI Patients - Blast; Chronic TBI Blast injury patients should have a history of head trauma manifesting in one or more of the following: Loss of consciousness; Post-traumatic amnesia; Focal neurologic deficits, seizure; Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance); Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).	Other: Blood/saliva sampling; one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
Healthy Volunteers; Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have,; No significant medical history; Take no medications (other than birth control pills); Fever free; No history of head trauma or recent injury/infection; No history of neurological or psychiatric disorders or alcohol or drug dependency.	Other: Blood/saliva sampling; one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomic analysis of plasma	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.	average of 6 months post injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomic analysis of saliva	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.	average of 6 months post injury

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Georgene Hergenroeder, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): March 3, 2016
• Study Completion (Actual): March 3, 2016

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimated): July 28, 2010

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: TBI; Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: HSC-MS-09-0334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No