Pro-2-Cool Device Clinical Study

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