Rapid diagnostic and prognostic marker predicting risk of brain damage and lasting dysfunction after mild traumatic brain injury (mTBI or concussion)
Mild traumatic brain injury (mTBI), alternatively referred to as concussion, is the most common neurological injury. mTBI affects more than 1.5 million children and adults each year in the U.S. alone, as well as hundreds of thousands of military personnel. mTBI is typically undetectable with computed tomography (CT), yet can elicit long-term and clinically significant brain dysfunction in 15–30% of cases.
Currently, there are neither a proven therapy for mitigating brain damage and improving long-term function, nor a test for identifying the small subset of concussion sufferers at risk of brain damage and in need of treatment. Consequently, new prognostic methods for mTBI are needed to identify at risk cases, especially at an early and potentially treatable stage.
Dr. Siman’s laboratory discovered that the blood level of the neurodegeneration biomarker calpain-cleaved αII-spectrin N-terminal fragment (SNTF) identifies mTBI patients that are likely to have both white matter structural damage and persistent brain dysfunction.
In concussion patients treated in the Emergency Room, increased plasma SNTF on the day of injury correlated significantly with neuroimaging abnormalities and with cognitive impairment that persisted for at least 3 months. In ice hockey players evaluated after an in-game concussion or concussion-free training, serum SNTF exhibited diagnostic accuracy for concussion, and within hours identified those cases that would go on to exhibit prolonged post-concussion symptoms requiring a delay in their return to play.
Brain microscopic studies confirmed that SNTF is a biologically plausible blood marker for concussion, accumulating preferentially in damaged axons after TBI.
Robert Siman, PhD
- Serum diagnostic and prognostic marker tested in peer reviewed human studies
- Currently the only blood marker rapidly predicting brain white matter damage and long-term dysfunction after concussion
- Biologically plausible: marker accumulates in white matter damaged by concussion
- Immunoassay uses a novel neoepitope-specific antibody with electrochemiluminescence detection chemistry that is the current method of choice in the biofluid diagnostics industry
Stage of Development:
- Two completed, published clinical studies and an on-going study in military personal exposed to blast
- Ongoing development of commercial blood test kit
Additional Media Coverage:
Docket # Z6565