Trial assessment device to identify concussion biomarker begins recruiting patients
A trial of a potential electrical biomarker for mild traumatic brain injury is currently recruiting adolescent and adult patients at the University of Texas Health Sciences Center at Houston (UTHealth Houston).
Led by Summer Ott, PsyD, associate professor in the Department of Orthopedic Surgery at McGovern Medical School at UTHealth Houston, the study will evaluate the effectiveness of Nurochek, a new FDA-cleared device, in early assessment of lesions traumatic brain injuries known as concussions.
The Nurochek device measures normal electrical activity in the brain using steady-state visual evoked potentials (SSVEPs) – a form of electroencephalographic (EEG) signals that are natural responses to visual stimulation at specific frequencies.
“As our program has evolved, we’re still looking for ways to objectively identify and diagnose concussion, but we’re also looking for ways to help athletes improve faster,” Ott said. , who is also director of the Concussion Program at Memorial Hermann IRONMAN Sports Medicine Institute. “We are actively involved in several projects surrounding the identification of new technologies and better intervention methods that can help achieve these goals.
Concussion occurs after a mild blow to the head, with or without loss of consciousness, and can cause temporary symptoms such as headaches, 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 each year and 10% of all contact sports athletes sustaining concussions each year, according to estimates from the Centers for Disease Control and Prevention.
Historically, SSVEPs have been performed on patients with neurological diseases. Ott thinks the protocol could provide objective information to help clinicians confirm a concussion diagnosis, instead of relying on patients’ self-reported symptoms.
“Athletes generally don’t want to be taken out of play, and when they reach the high school level they are susceptible to various types of injuries, including concussion. Other times an athlete may quickly ignore their symptoms following a dehydration headache,” Ott said. “You make an injury worse by not identifying it in time to treat it properly. Nurochek could help us sort out these unclear situations.
Although there is no specific treatment for concussions, patients are generally advised to rest, reduce use of electronic devices, and take prescribed medications before returning safely to hospital. school and then to sports.
The multi-site study, which aims to enroll a total of 360 participants, will recruit adolescents aged 14 to 17 and adults aged 18 to 35 who present within 72 hours of suspected concussion. At the UTHealth Houston site, Ott hopes to screen 200 people for a target recruitment 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 which is the standardized test, at each visit.
For more information about the trial, call 713-486-3435.
Media inquiries: 713-500-3030