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

Completed
Conditions
Traumatic Brain Injury
Registration Number
NCT01171131
Lead Sponsor
The University of Texas Health Science Center, Houston
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
96
Inclusion Criteria

Chronic TBI patients:<br><br>Inclusion Criteria<br><br>Have a history of head trauma manifesting in one or more of the following:<br><br> - Loss of consciousness<br><br> - Post-traumatic amnesia<br><br> - Focal neurologic deficits, seizure<br><br> - Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep,<br> anger and hypervigilance)<br><br> - Impairment in social, occupational, or other important areas of functioning (e.g.<br> problems with work and relationships.)<br><br>Exclusion Criteria<br><br>Inability to obtain informed consent and if they are non-communicative (i.e. in a<br>vegetative state).<br><br>Healthy volunteers:<br><br>Inclusion Criteria<br><br> - No significant medical history<br><br> - Take no medications (other than birth control pills)<br><br> - Fever free<br><br> - No history of head trauma or recent injury/infection<br><br> - No history of neurological or psychiatric disorders or alcohol or drug dependency.<br><br>Exclusion Criteria<br><br> - Inability to provide informed consent<br><br> - age/gender match not available in TBI cohort

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proteomic analysis of plasma
Secondary Outcome Measures
NameTimeMethod
Proteomic analysis of saliva
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