Pro-2-Cool Device Clinical Study: an Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population
This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.
• Males and females ages 12 - 21 years
• Initial provider visit is within 8 days of mTBI injury
• Confirmed mTBI diagnosis from sporting activities
• In generally good health as confirmed by medical history and as determined by site investigator
• Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
• Has informed consent obtained per protocol and as required per Institutional Review Board (IRB)