Hypothermic therapy device shows promise in treating concussions

TecTraum Inc. announced complete enrollment status for a clinical trial evaluating its pro2cool device, a noninvasive hypothermic therapy system for treating concussions.

The device, designed to decrease the severity of concussion symptoms, provides localized cooling for the head and neck to lower blood temperature before reaching the brain, the company stated in a press release.

According to the CDC, as many as 3.8 million sports and recreation-related concussions occur annually in the United States. In addition, from 2001 to 2012, emergency room visits doubled among children with concussions.

Following the completion of pilot studies for pro2cool, investigators enrolled 174 participants, aged 12 to 21 years, to further evaluate the device’s efficacy, safety and tolerability. The University of Michigan’s CS Mott Children's Hospital, Akron Children's Hospital, Dayton Children's Hospital and Cincinnati Children’s Hospital Medical Center served as investigational sites.

“As the principal investigator in the study we are thankful for the hard work of the research team from Akron Children’s Hospital,” Joseph A. Congeni, MD, of Akron Children's Hospital, said in the release. “We also appreciate the coordination and communication demonstrated in this study by all of the researchers in this multicenter effort.”

According to the release, hypothermic therapy has been clinically effective in treating various cardiovascular injuries, including cardiac arrest and myocardial infarction. The physiologic neuroprotective benefit from cooling the injured area appears to occur at the cellular level and involves disrupting the body’s inflammatory response. By cooling the region, the cellular metabolic cascade is weakened and subsequent damage caused by the body is minimized.