Mild and Moderate TBI Biomarker Study

Study ID
STU 012012-024

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Cari Stebbins
214/648-7609
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.

To detect alterations in pupil dilation, the neuroTrak oculomotor tracking device will also be administered at baseline (sports athletes only) and on day 1, 3, 8, 14, 30, and 180 after injury. The neuroTrak oculomotor tracking device is a headset similar to binoculars and the eye movements will be tracked. a set of video cameras inside of the device will record the responses to either white, red, or blue LeD lights. The testing takes approximately 1 minute. eeG will be administered at baseline (sports athletes only) and on day 1, 30, and 180 after injury. in brief, eeG signals will be recorded for approximately 30 minutes from 23 channels based on the international 10x20 system (Fp1, Fp2, Fz, F3, F7, F4, F8, FT9, FT10, Cz, T3, T7, T4, T8, Pz, P3, P7, P4, P8, C3, C4, o1, and o2). in addition, the vertical and horizontal electro-oculograms (eoGs) will be recorded to monitor the eye movements and blinks. Hyperventilation will be performed in the supine position for 3 minutes. Photic stimulation will be performed from 1-30 Hz with 10 second trials and testing with the eyes opened and closed. The eeG signals will be sampled at the frequency of 200 Hz, reformatted and digitally filtered in a variety of bipolar and referential montages for optimal display. The Persyst software will be used for quantitative eeG analysis.

Within these TBi population, it is hypothesized that detection of biomarkers of injury 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