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

NCT01171131 | Completed

• 1 other identifier: HSC-MS-09-0334
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

TBI; Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proteomic analysis of saliva

  average of 6 months post injury

Study Arms (3)

Chronic TBI Patients - Non-penetrating

Chronic TBI patients should have a history of head trauma manifesting in one or more of the following: 1. Loss of consciousness 2. Post-traumatic amnesia 3. Focal neurologic deficits, seizure 4. Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) 5. 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

Chronic TBI Patients - Blast

Chronic TBI Blast injury patients should have a history of head trauma manifesting in one or more of the following: 1. Loss of consciousness 2. Post-traumatic amnesia 3. Focal neurologic deficits, seizure 4. Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) 5. 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

Healthy Volunteers

Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have, 1. No significant medical history 2. Take no medications (other than birth control pills) 3. Fever free 4. No history of head trauma or recent injury/infection 5. No history of neurological or psychiatric disorders or alcohol or drug dependency.

Other: Blood/saliva sampling

Interventions

Blood/saliva sampling OTHER

one-time blood sample (\~ 1 TBS) and saliva sample (\~ 1 tsp)

Chronic TBI Patients - Blast; Chronic TBI Patients - Non-penetrating; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TIRR Clinics

You may qualify if:

• 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.)

You may not qualify if:

• Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
• Healthy volunteers:
• 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.
• Inability to provide informed consent
• age/gender match not available in TBI cohort

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

TIRR

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample Blood sample (plasma)

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Georgene Hergenroeder, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 28, 2010
• Study Start: April 1, 2010
• Primary Completion: March 3, 2016
• Study Completion: March 3, 2016
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)