Traumatic Brain Injury (TBI)

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The Public Health Challenge

Traumatic brain injury (TBI) is the leading cause of mortality in persons under 45 years old, and a leading cause of disability in all age groups. In civilians, TBI is caused by car crashes, falls, sports, assaults and it is emerging as a potential threat in civilian terrorism. In the military, blast TBI caused by improvised explosive devices is one of the most serious wounds currently suffered by U.S. combat troops in Iraq and Afghanistan. Even a mild TBI (mTBI, a concussion) can result in a severe neurocognitive impairment called post-concussional disorder (PCD). PCD develops in about 20% of mTBI patients within 3 to 12 months after the injury. PCD involves persistent memory loss, headaches, balance problems, hearing problems, lack of self-control, mood changes, ringing in the ears, problems sleeping and cognitive deficits. These problems impair employment, disrupt stable social relationships can isolate the individual to a narrow world of disability and reduced opportunity. Soldiers or athletes with mTBI injuries typically return to the field. This can lead to cumulative concussions that increase the risk of PCD. In soldiers, PCD severely interferes not only with performance in the field but also with the ability to live a normal life after deployment. Early diagnosis and treatment of mTBI injuries is critical to minimize physical and mental disability, co-morbidity, substance abuse and suicidal behavior. The main challenge in predicting PCD risk is the lack of a rapid test that could be used for routine monitoring of mTBI patients in point-of-care settings (POC). Currently, PCD diagnostics is based on neuropsychological tests. These tests are costly, time-consuming and do not discriminate between patients who will have spontaneous symptom resolution from those who will have persistent complaints.

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Our Techonology as a Solution

Responding to this need, our goal is to develop a rapid oral test suitable for monitoring mTBI patients in POC. The test will be based on Stress Response Profiling (SRP) biomarkers in saliva, a new patent pending technology developed by Gaia Medical. Currently we are performing a clinical study in collaboration with the Traumatic Brain Research Center at Pittsburgh University. The study will deliver a validated panel of biomarkers for detecting PCD risk. A commercial test will be developed in 3 to 5 years. The new test will be a simple hand-held device similar to the home pregnancy test and will utilize lateral-flow immunoassay technology. The test will be pain-free, affordable, and suitable for field use. Test results will indicate risk of PCD. This will be useful for deciding whether a TBI patient should start a treatment, or modify the current treatment because it is not working well. The proposed test has potential to significantly accelerate the delivery of treatment for mTBI by enabling rapid simple forecasting of PCD risk and individualized therapeutic monitoring.