A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Interventions
- Other: Blood/saliva sampling
- Registration Number
- NCT01171131
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic TBI Patients - Blast Blood/saliva sampling 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). Healthy Volunteers Blood/saliva sampling 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. Chronic TBI Patients - Non-penetrating Blood/saliva sampling 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).
- Primary Outcome Measures
Name Time Method Proteomic analysis of plasma 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 Outcome Measures
Name Time Method Proteomic analysis of saliva 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.
Trial Locations
- Locations (1)
TIRR
🇺🇸Houston, Texas, United States