AKRON, Ohio — For years, athletic trainers have comforted athletes with suspected concussions with an ice towel. It appears they were on to something.
Researchers at Akron Children's Hospital — along with Cincinnati Children’s Hospital, the University of Michigan, and Dayton Children's Hospital — found using a device that cools the brain helps to reduce the severity of concussion symptoms. It's known as hypothermic therapy.
The study, published in the Clinical Journal of Sports Medicine, found that cooling the head and neck with a device after a mild brain injury reduced Sport Concussion Assessment Tool (SCAT5) symptom scores by 14% after initial treatment with pro2cool's hypothermic therapy. After a second treatment using the pro2cool system, SCAT5 scores were 25% lower than those receiving standard concussion care.
Cleveland-based Tectraum created the pro2cool device and received FDA breakthrough device designation in December of 2021. The company provided the device for the study of 167 patients aged 12-19.
"We wanted to study younger people because so many studies have been done on college athletes, pro athletes, and those people are the tip of the iceberg," Dr. Joseph Congeni, Akron Children's Hospital's medical director of sports medicine, said. "We see more high school and junior high school athletes. The majority of subjects were between 12 and 16."
Study participants all received a concussion within eight days of study enrollment. Half received standard concussion treatment and the other half received two thirty minute sessions with the pro2cool system.
Following the initial evaluation and treatment, the groups were further evaluated at later time points – 72 hours, 10 days, and 28 days – with the second round of treatment occurring at 72 hours.
Dr. Congeni says it is the first and only concussion treatment study of this population, and the largest single concussion therapy trial known to date.
Sports-related concussions are a significant problem in younger children between 12 and 17. In the U.S. about 80%-90% of sports-related concussion symptoms in adolescents resolve in 17 to 28 days, longer than the 7-to 10-day recovery time for adults.
Dr. Congeni says more research is needed to see if getting the pro2cool device to the athlete immediately after or within 24 hours of concussion makes a difference. He adds that that the device has little risk and is not invasive.
According to Dr. Congeni, the Tectraum device is awaiting full FDA approval, which is expected to come as early as June.