ROCHESTER, N.Y. (July 12, 2023) A first-of-its-kind large-scale study conducted by the Kutcher Clinic for Sports Neurology aims to evaluate and refine how concussions are identified and treated using evidence-based diagnostic inputs. The study is funded in part by the neuroscience technology company Cognivue, which specializes in testing cognitive function.

“There’s an idea that every head trauma incident that causes symptoms must be a concussion, and that’s absolutely not true,” said Jeffrey Kutcher, MD, FAAN, Global Director for the Kutcher Clinic. “What our research is going to do, for the first time, is stratify patients based on the certainty of their concussion diagnosis, using careful consideration of the mechanism of injury—for instance, how big was the hit or how hard was the hit— alongside our own comprehensive neurological evaluation. The true goal is diagnostic certainty leading to real research insights.”

Researchers will assess 90 adults with definite or probable concussions diagnoses over a two-year period. Each person enrolled will be seen and evaluated within 48 hours of the initial impact, then seven days and six months later. A 30-person non-concussed group will serve as a control.

The study will evaluate how Cognivue Clarity® technology behaves when it comes to definite and probable concussions. Cognivue’s FDA-cleared computerized testing tools are designed to assess early signs of cognitive impairment.

“We are regularly approached by groups saying they can change the world of concussion, especially when it relates to cognition, but few have held up—especially under clinical conditions,” said Dr. Kutcher. “Our research team will clarify how Cognivue performs in the concussion setting, such that we can inform others who need to diagnose and treat concussion in real time about a potential, evidence-based tool.”

“When Dr. Kutcher approached us to participate in the study, we jumped at the chance,” said Tom O’Neill, CEO of Cognivue. “No matter the healthcare segment in which Cognivue technology is used, we want clinicians to have full confidence in its capabilities to aid in screening and diagnosis. That’s why we continue to engage in multiple studies with some of the world’s most respected clinical, research, academic, and advocacy organizations, including our latest initiative with The Kutcher Clinic.”

Three other diagnostic tools will also be included as part of the study. They are Eye-Sync, a virtual reality-based platform that measures brain performance by analyzing eye movements; NeuroCatch, which evaluates brain activity using event-related potentials (ERPs); and NfL (Neurofilament Light Chain), a blood biomarker.

Enrollment will begin by August 1 among Kutcher Clinic patients, primarily athletes, from the Detroit and surrounding area. Additional study support is being provided by major professional athletic associations.

About The Kutcher Clinic

The Kutcher Clinic for Sports Neurology specializes in diagnosing and managing concussion, post-concussion syndrome, and neurological conditions in athletes. It treats patients through a personalized approach to diagnosis, management, and return-to-life decisions. The Kutcher Clinic has two locations in Detroit and Park City, Utah. For more information, visit thesportsneurologyclinic.com.

About Cognivue, Inc.

Cognivue, Inc. is a world-class neuroscience company focusing on cognitive health with the world’s first FDA-cleared computerized test of cognitive function. The Cognivue device and technology are based on years of research that uses adaptive psychophysics to focus on information processing by testing key cognitive domains. The technology significantly improves the ability of healthcare providers to implement a personalized assessment of cognitive function in a wide variety of care settings. The company is elevating the gold standard of cognitive health assessment and empowering the healthcare community to monitor, identify and act early on cognitive health concerns. For more information, call (585) 203-1969 or visit cognivue.com.