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

NCT ID: NCT01171131

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-03-03

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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).

Blood/saliva sampling

Intervention Type: OTHER

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:

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).

Blood/saliva sampling

Intervention Type: OTHER

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,

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.

Blood/saliva sampling

Intervention Type: OTHER

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

Interventions

Blood/saliva sampling

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

Intervention Type: OTHER

Eligibility Criteria

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.)

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

Healthy volunteers:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Georgene Hergenroeder

Associate Professor, Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgene Hergenroeder, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

TIRR

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-09-0334

Identifier Type: -

Identifier Source: org_study_id