Mild and Moderate TBI Biomarker Study

Study ID
STU 012012-024

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Cari Stebbins
214/215-1607
cari.stebbins@utsouthwestern.edu

Principal Investigator
Joshua Gatson

Summary

each year in the united States alone, approximately 1.4 million people experience a traumatic brain injury (TBi) event that requires hospitalization. of these TBi injuries about 75% are mild traumatic brain injuries (mTBi). To date, there are no effective fluid-based detection systems aimed at predicting neurological outcome after injury. identification of the levels of neural markers of injury soon after injury may help in the management of TBi and alleviate or prevent secondary injury and subsequent development of cognitive deficits. after injury, increased oxidative stress and inflammation in the brain leads to the demise of neuronal populations and ultimately decreased brain function. identification of neural markers such as tau, amyloid-beta, and neuronal specific enolase (nSe) at the early time-points after brain injury can help us better understand the multitude of such secondary injuries following TBi and may help predict outcome in these individuals affected by TBi. To measure these fluid-based neural markers of injury, blood and saliva samples will be collected from sports athletes prior to injury (baseline) and in concussed athletes (boxers/football players). The samples will be obtained on day 1, 3, 7, and 14 after injury. From patients hospitalized with a mild TBi will have blood and saliva collected at 1, 3, 8, 14, 30, 180 days after injury. in addition, patients with moderate TBi will be enrolled in the study. Blood will be collected on day 1, 3, 8, and 14 after injury. Following collection of these samples, the levels of neural markers of injury will be measured using Western analysis and the eLiSa method. To assess cognitive deficits after injury, we will administer the imPaCT test at baseline and at the time of the blood draw in the athletes. Within these TBi population, it is hypothesized that detection of neural markers of injury in the blood will correlate with long-term neurological outcomes.

Participant Eligibility

1. Study Participants between the ages 18-50 years old
2. Both men and women
3. Mild TBI: Athletes with an estimated concussion (Mild-Moderate-Severe) or patients
admitted to Parkland hospital with a GCS between 13 and 15
4. Moderate TBI: Patients admitted to Parkland hospital with a GCS between 9 and 12
5. Subject has provided full written informed consent prior to the performance of any
protocol-specified procedure