Pro-2-Cool Pivotal Trial II

This is a multi-center, prospective, randomized, double-blinded, dual-arm comparative study enrolling up to a total of 66 patients (approximately 33 patients in the treatment arm and 33 patients in the control arm) following sports-related, concussion.

Inclusion criteria

• Males and females, 13-21 years of age
• Confirmed concussion diagnosis consistent with American Congress Rehabilitation Medicine guidelines 21, without any of the following:

• Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury
• Loss of consciousness greater than 30 minutes
• Post-traumatic amnesia lasting over 24 hours
• Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
• Post-Concussion Symptom Scale Score minimum of 15
• Initial provider visit is within 7 days of injury
• In generally good health as confirmed by medical history and determined by site investigator or designated trained healthcare professional under the supervision of the principal investigator.
• Has informed consent obtained per protocol and as required per Institutional Review Board

Exclusion criteria

• Age < 13 years or > 21 years
• Inability to understand the study requirements or provide informed consent
• Cleared to return to play during initial visit
• Prior participation in a Pro2Cool Clinical Study
• Serious traumatic brain injury as evidenced by worsening symptoms:

• Vomiting > 2 episodes following injury
• Seizure
• Hospitalization
• Radiology scan indicating brain bleed
• Slurred speech which has not resolved within 72 hours of concussive injury
• Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms
• Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
• History of psychiatric disorder that includes suicide attempts within the last 6 months, unmanaged depression or anxiety, hospitalization for psychiatric treatment within the last 6 months
• Known brain mass, intracranial hemorrhage, skull fracture
• Scalp abnormalities including laceration or bleeding
• Presence of ventriculoperitoneal (VP) shunt
• Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
• Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines
• Known or disclosed pregnancy or breast-feeding
• Sustains another head or neck injury at the time of concussive injury which requires medical treatment