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

A Pilot Study to Identify Biomarkers Associated With Chronic TBI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01171131
Acronym
Chronic TBI
Enrollment
96
Registered
2010-07-28
Start date
2010-04-01
Completion date
2016-03-03
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

TBI, Brain Injury

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.

Interventions

OTHERBlood/saliva sampling

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

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Proteomic analysis of plasmaaverage of 6 months post injuryThe 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

MeasureTime frameDescription
Proteomic analysis of salivaaverage of 6 months post injuryThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGeorgene Hergenroeder, PhD

The University of Texas Health Science Center, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026