Pro-2-Cool Device Clinical Study

This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study.

Subjects will be assigned to study arm based on a block randomization schedule generated a priori.

The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.

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