Pro-2-Cool Device Clinical Study

Inclusion Criteria: * 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) Exclusion Criteria: * Cleared to return to play during initial visit * Suffers a serious TBI as evidenced by worsening symptoms, specifically: * Seizure * Hospitalization * Existing positive diagnostic testing, which include radiology scans that indicate brain bleed * Slurred speech, which has not resolved within 72 hours of mTBI injury * Sustains another head or neck injury at the time of mTBI injury which requires medical treatment * Known or disclosed pregnancy or breast-feeding * History of a serious medical or psychiatric disorder that include: * Suicide attempt in the last 6 months * Unmanaged depression or anxiety * Hospitalization in the last 6 months for psychiatric treatment * History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia * Previously diagnosed with a cerebrovascular disorder * Is unable to understand the study requirements or the informed consent * Currently enrolled in another investigational research study that may confound the results of this study * Non-English speaking subjects and parents/legal guardians