Akron Children’s seeks young athletes for concussion clinical trial

02-04-2019 ( Ohio )

Akron Children’s is seeking youth athletes who have suffered a concussion to become participants in a clinical trial studying whether cooling the brain after the concussion, similar to icing an injured muscle, can reduce symptoms and speed up recovery time.

In the past decade, concussion has emerged as a major concern in youth, college and professional sports. Approximately 1 in 5 high school athletes suffer a sports-related concussion during each season. Football players suffer the most concussions, but numbers have been increasing in sports such as lacrosse, women’s basketball and soccer.

“The standard of care for concussion has been brain rest until symptoms resolve. But, this study can play an important role in discovering how concussions are treated in the future,” said Dr. Joe Congeni, director of Sports Medicine at Akron Children’s and the principal investigator for the study.

The Pro-2-Cool™ concussion therapy study team seeks young athletes between the ages of 12 and 19, who are generally in good health but who have been diagnosed with a concussion. Athletes who pass the initial screening will be randomly assigned to either receive the cooling therapy and brain rest or brain rest alone.

If selected to receive the cooling therapy, the first treatment will be administered during the initial clinic visit and again within 72 hours in the sports medicine clinic. Athletes will follow normal return-to-play protocol, overseen by a provider.

“The Pro-2-Cool system is a non-invasive hypothermic (cold therapy) device that delivers localized cooling to the head and neck,” said Dr. Congeni. “Just like icing a hurt knee or ankle, cooling the blood may reduce swelling and prevent early cellular damage. Cooling therapy has long been used in treating heart attacks and brain injury in newborns. We are excited to see where this research takes us in concussion treatment.”

The study is sponsored by TecTraum, Inc., a Cleveland-based biomedical engineering company, which has financial backing from two former NFL players, Sam Williams and Justin Fargas, of the Oakland Raiders.

“Our 15 years of combined NFL experience has exposed us to a number of concussions,” said Williams. “We experienced them at a time when the NFL considered them a non-issue and, then once they became a hot button issue, towards the end of our careers. Learning there was a cooling device that might help treat concussion was enough for us to invest our money and time to develop the technology and research its effectiveness.”

For more information about the clinical trial, go to www.akronchildrens.org/pro2cool. If your child has suffered a sports-related concussion in the past 8 days and is still experiencing symptoms, he or she could be eligible to participate. If you are interested in him or her being evaluated for the study, call 330-543-8260.