Status:
COMPLETED
A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
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 accom...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 3 2016
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01171131
Start Date
April 1 2010
End Date
March 3 2016
Last Update
August 7 2025
Active Locations (1)
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1
TIRR
Houston, Texas, United States, 77030