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Completed

NCT Number: NCT01171131

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TIRR

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood/saliva sampling

Other

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

Primary outcomes

  1. Proteomic analysis of plasma

    Time frame: 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 outcomes

  1. Proteomic analysis of saliva

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

A Pilot Study to Identify Biomarkers Associated With Chronic TBI

Acronym: Chronic TBI

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2010
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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