Traumatic Brain InjuryChronic TBINCT01171131
A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Blood/saliva sampling
- Type of treatment
- Pill or oral medicine
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 3 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TIRR Clinics
Who may be able to join
- 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.)
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Identify Biomarkers Associated With Chronic TBI
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
- Being tested
- Blood/saliva sampling
- Keywords
- TBI, Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood/saliva samplingOther
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Other: Blood/saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: average of 6 months post injury
Secondary outcomes (1)
Proteomic analysis of saliva
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.
Measured: average of 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startApr 2010
- Primary completion3 Mar 2016
- Study completion3 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgene Hergenroeder, The University of Texas Health Science Center, Houston
- Investigators
- Georgene Hergenroeder, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171131
- Sponsor's protocol ID
- HSC-MS-09-0334
- Acronym
- Chronic TBI
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2010
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Identify Biomarkers Associated With Chronic TBI
- ClinicalTrials.gov ID
- NCT01171131
- Acronym / sponsor ID
- Chronic TBI / HSC-MS-09-0334
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- 3 Mar 2016 (actual)
- Study completion
- 3 Mar 2016 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic TBI Patients - Non-penetrating | – | Other: Blood/saliva samplingChronic 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). |
| Chronic TBI Patients - Blast | – | Other: Blood/saliva samplingChronic 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). |
| Healthy Volunteers | – | Other: Blood/saliva samplingHealthy 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TIRR Clinics
Key inclusion criteria (11 listed)
- 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.)
Key exclusion criteria (4 listed)
- Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
- Inability to provide informed consent
- age/gender match not available in TBI cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood/saliva samplingone-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp) | Other | Chronic TBI Patients - Blast, Chronic TBI Patients - Non-penetrating, Healthy Volunteers |
Primary outcome
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.
1 secondary outcome
Proteomic analysis of saliva
Time frame: average of 6 months post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgene Hergenroeder, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic analysis of plasma (time frame: average of 6 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.