Trial evaluating device to identify a concussion biomarker begins recruiting patients
A trial investigating a potential electric biomarker for mild traumatic brain injury is now recruiting teenage and adult patients at The University of Texas Health Science Center at Houston (UTHealth Houston).
Led by Summer Ott, PsyD, associate professor in the Department of Orthopedic Surgery with McGovern Medical School at UTHealth Houston, the study will evaluate the effectiveness of Nurochek, a new FDA-cleared device, in the early assessment of mild traumatic brain injuries known as concussions.
The Nurochek device measures the brain’s normal electrical activity using steady state evoked visual potentials (SSVEPs) – a form of electroencephalograph (EEG) signal that are natural responses to visual stimulation at specific frequencies.
“As our program has evolved, we’re always looking for ways we can objectively identify and diagnose a concussion, but we’re also looking for ways we can help athletes get better more quickly,” said Ott, who is also director of the Memorial Hermann IRONMAN Sports Medicine Institute Concussion Program. “We are actively involved in several projects surrounding the identification of new technologies and better intervention methods that can assist with these goals.”
Concussion occurs after a mild blow to the head, either with or without loss of consciousness, and can lead to temporary symptoms such as headache, confusion, lack of coordination, memory loss, nausea, and excessive fatigue, among others. These brain injuries are extremely common, with more than 3 million Americans diagnosed annually and 10% of all contact sports athletes sustaining concussions yearly, according to estimates from the Centers for Disease Control and Prevention.
Historically, SSVEPs have been performed on patients with neurological disease. Ott believes the protocol could provide objective information to help clinicians confirm a concussion diagnosis, as opposed to relying on self-reported symptoms from patients.
“Athletes generally don’t want to be removed from play, and when they get up to the high school level, they’re likely to play through various types of injuries, including concussion. Other times, an athlete may quickly dismiss his or her symptoms as the result of a dehydration headache,” Ott said. “You make an injury worse by not identifying it in time to treat it properly. Nurochek could help us tease apart these unclear situations.”
While there is no specific treatment for concussion, patients are typically recommended to rest, reduce use of electronic devices, and take prescribed medications before safely returning to school and then sports.
The multisite study, which aims to enroll a total of 360 participants, will recruit adolescents ages 14 to 17 and adults ages 18 to 35 who present within 72 hours of a suspected concussion. At the UTHealth Houston site, Ott hopes to screen 200 individuals for a target enrollment of 100 subjects.
Participants will report for four, 30-minute visits over a four-week period, completing two assessments, the Nurochek and the Sport Concussion Assessment Tool Edition 5 that is the standardized test, at each visit.
