Using a Blood Marker to Predict Concussion Risk and Severity

This patent describes a method to diagnose and predict long-term issues from mild traumatic brain injury, like concussions, by measuring a specific protein fragment called SNTF in a blood sample.

What it covers

The patent outlines a method to assess mild traumatic brain injury (mTBI), including sports-related concussions, by analyzing a blood sample. First, a blood, serum, or plasma sample is taken from a subject within 36 hours of the injury (Claim 1a, 12a). Next, this sample is mixed with a special antibody that specifically attaches to a broken piece of a protein called SNTF, but not to the whole protein (Claim 1b, 12b). The amount of this antibody-SNTF combination is then measured to find the SNTF concentration (Claim 1c, 12c). This concentration is compared to a pre-determined normal level (Claim 1d, 12d). If the SNTF level is higher than normal, it indicates an elevated risk of long-term brain problems (Claim 1e) or the severity of the mTBI (Claim 12e), leading to a prognosis or diagnosis and subsequent treatment (Claim 1f, 12f). For example, a football player suspected of a concussion could have their blood tested to determine their risk of long-term issues and suitability to return to play (Claim 11).

What it doesn't cover

• —Diagnostic methods that do not rely on measuring the specific calpain-cleaved αII-spectrin N-terminal fragment (SNTF) in a blood, serum, or plasma sample.
• —Blood, serum, or plasma samples collected more than 36 hours after the mild traumatic brain injury or suspected concussion occurred.
• —Antibodies that bind to the full-length spectrin protein, rather than specifically to the calpain-generated neoepitope of SNTF (Claim 1b, 12b).
• —Diagnostic or prognostic methods for brain injuries that are not classified as mild traumatic brain injuries (mTBI).
• —Methods that do not involve comparing the measured SNTF concentration to a pre-determined standard (Claim 1d, 12d).

The clever bit

The novelty lies in identifying and utilizing the specific calpain-cleaved αII-spectrin N-terminal fragment (SNTF) as a blood biomarker. This particular fragment, generated by specific enzyme activity after brain injury, provides a precise and measurable indicator for both diagnosing mTBI and predicting the risk of long-term neurological dysfunction.

Why it matters

Concussions and other mild traumatic brain injuries are common, especially in sports, and can have serious long-term consequences. Diagnosing them objectively and predicting outcomes has been challenging, often relying on subjective assessments or expensive imaging like CT scans. This patent offers a blood-based, objective biomarker test that can be performed relatively quickly after an injury, potentially allowing for earlier and more accurate prognosis and diagnosis without the need for a CT scan (Claim 7, 16). This could significantly improve patient management and safety, particularly for athletes.

Real-world examples

• 1.Concussion assessment in professional sports leagues
• 2.Emergency room diagnostics for head injuries
• 3.Monitoring recovery of athletes after a head impact
• 4.Clinical trials for new mTBI treatments