Pro-2-Cool Pivotal Trial II

Launched by TECTRAUM INC. · Apr 14, 2025

Keywords

ClinConnect Summary

The Pro-2-Cool Pivotal Trial II is a study looking at a new way to help young people who have mild traumatic brain injuries (mTBI) from sports. Specifically, this trial is testing a cooling device that is applied to the head and neck to see if it can improve recovery and reduce symptoms after an injury. The trial is open to adolescents aged 12 to 21 years who have been diagnosed with mTBI within 8 days of their injury and have a specific level of symptoms.

To participate, individuals must be in generally good health and have a symptom score of at least 7. However, those who are cleared to return to play right after their injury or have more serious brain injuries or certain medical issues won't be eligible. Participants will receive the treatment and will be closely monitored throughout the study to assess its safety and effectiveness. If you or someone you know fits these criteria and is interested, this might be a great opportunity to help understand how cooling therapy can aid recovery from sports-related head injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 1. Cleared to return to play during initial visit
• 2. Suffers a serious TBI as evidenced by worsening symptoms, specifically:
• • 2.1. GCS \<14 2.2. Seizure 2.3. Hospitalization 2.4. Existing positive diagnostic testing which include radiology scans that indicate brain bleed 2.5. 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. History of a serious medical or psychiatric disorder that include:
• • 4.1. Suicide attempt in the last 6 months 4.2. Unmanaged depression or anxiety 4.3. Hospitalization in the last 6 months for psychiatric treatment
• • 5. History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
• • 6. Previously diagnosed with a cerebrovascular disorder
• • 7. Is unable to understand the study requirements or the informed consent
• • 8. Currently enrolled in another investigational research study that may confound the results of this study
• • 9. Non-English speaking subjects and parents/legal guardians