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

The University of Texas System (UT)

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: Blood/saliva sampling

Study type: Observational

Funder types: Other

Identifiers

NCT01171131

HSC-MS-09-0334

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Exclusion Criteria

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

Trial design

96 participants in 3 patient groups

Chronic TBI Patients - Non-penetrating

Description:

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).

Treatment:

Other: Blood/saliva sampling

Chronic TBI Patients - Blast

Description:

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).

Treatment:

Other: Blood/saliva sampling

Healthy Volunteers

Description:

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.

Treatment:

Other: Blood/saliva sampling