AKRON, Ohio, April 2, 2024 /PRNewswire/ -- Researchers at Akron Children's, Cincinnati Children's, University of Michigan and Dayton Children's Hospital, have found that hypothermic therapy reduces symptom severity after concussion.
In a study published in the Clinical Journal of Sport Medicine, researchers found that providing selective surface cooling to specific areas in the head and neck after 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.
Study participants were aged 12–19, had received a concussion within eight days of study enrollment, and were placed in one of two groups: one using the standard treatment of care — rest; and the other receiving two treatments 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.
It is the first and only concussion treatment study of this population, and the largest single concussion therapy trial known to date.
"Traditionally, ice has been used to reduce pain and swelling in muscle injuries," said Dr. Joseph Congeni, director of sports medicine at Akron Children's and lead study investigator at Akron Children's Rebecca D. Considine Research Institute. "Now, this research – along with our previously published pilot study using pro2cool – has found the same to be true for concussions.
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 children aged 12 to 17 in the U.S. About 80%-90% of sports-related concussion symptoms in adolescents resolve in 17 to 28 days, longer than the seven- to 10-day recovery time for adults.
And while safeguards continue to be put in place to prevent concussions, little has been done to change the treatment of care for a concussion when one does happen. Traditionally, adolescent concussions have been treated with brain rest — refraining from strenuous physical and mental tasks – until symptoms resolve. Now, in addition to brain rest, concussion symptoms can be treated with selective hypothermic therapy.
"We know from what we see on athletic fields and the feedback we receive from parents and kids that brain rest isn't enough," said Dr. Congeni. "The results of this study show the standard of concussion care can be improved upon."
The study has important clinical implications:
Adolescents with concussions may benefit from receiving multiple treatments with the pro2cool® system to reduce the severity of their symptoms.
The pro2cool system used to deliver the therapy is well-tolerated, indicating an initial positive safety profile absent of major adverse effects.
"While this publication marks the end of this particular study, the work has just begun," said Dr. Matthew Smith, staff scientist, Rebecca D. Considine Research Institute at Akron Children's and assistant professor, co-director, Basic and Translational Biomedicine Graduate Program, Northeast Ohio Medical University. "There are a variety of questions left to be explored, for example, 'If we use the device to treat sooner, more often, and for longer, then can we improve/maximize the clinical benefit?' Additionally, understanding how these therapeutic effects are achieved at the biological level will be critical in creating personalized treatment protocols for each patient."
TecTraum Inc., the makers of the smart technology pro2cool, supplied the device used in the study, which is currently under review by the U.S. Food and Drug Administration (FDA).
Related article: TecTraum's pro2cool Receives FDA Designation as Breakthrough Device
Citation: Smith, Matthew A. MS, PhD, McNinch, Neil L. MS, RN, PSTAT, et al. Clinical Journal of Sport Medicine Epub ahead of print January 5, 2024 DOI: 10.1097/JSM.0000000000001198
About Us: Nottingham Spirk is a world-class product innovation firm with an unrivaled record of developing and commercializing disruptive consumer products, medical devices, digital IoT products, and connected industrial products. We collaborate with Fortune 1,000 companies, middle market companies, and funded venture companies to discover, design and execute product innovation programs and strategic business platforms that will delight customers, grow markets, and generate new revenue streams. Learn more about Nottingham Spirk's expertise with medical device design.