An assessment of clinical efficacy of hypothermic therapy following Pivotal Trial II (mTBI) in the adolescent athlete

Who May Qualify:

1. Males and females ages 12 – 21 years
2. Initial provider visit is within 8 days of mTBI injury
3. Confirmed mTBI diagnosis from sporting activities
4. In generally good health as confirmed by medical history and as determined by site investigator
5. Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
6. Has informed consent obtained per protocol and as required per IRB

Who Does NOT Qualify:

1. Cleared to return to play during initial visit
2. Suffers a serious TBI as evidenced by worsening symptoms, specifically:
   1. GCS <14
   2. Seizure
   3. Hospitalization
   4. Existing positive diagnostic testing which include radiology scans that indicate brain bleed
   5. Slurred speech, which has not resolved within 72 hours of mTBI injury
3. Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
4. Known or disclosed pregnancy or breast-feeding
5. History of a serious medical or psychiatric disorder that include:
   1. Suicide attempt in the last 6 months
   2. Unmanaged depression or anxiety
   3. Hospitalization in the last 6 months for psychiatric treatment
6. History of Reynaud’s disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
7. Previously diagnosed with a cerebrovascular disorder
8. Is unable to understand the study requirements or the informed consent
9. Currently enrolled in another investigational research study that may confound the results of this study
10. Non-English speaking subjects and parents/legal guardians