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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Identify Biomarkers Associated With Chronic TBI

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: Blood/saliva sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic TBI Patients - Non-penetrating<br>Chronic TBI patients should 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.) 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). | Other: Blood/saliva sampling<br>* one-time blood sample (  1 TBS) and saliva sample (  1 tsp)<br>|
| Chronic TBI Patients - Blast<br>Chronic TBI Blast injury patients should 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.) 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). | Other: Blood/saliva sampling<br>* one-time blood sample (  1 TBS) and saliva sample (  1 tsp)<br>|
| Healthy Volunteers<br>Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have, 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. | Other: Blood/saliva sampling<br>* one-time blood sample (  1 TBS) and saliva sample (  1 tsp)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | average of 6 months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | average of 6 months post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Brain Injury