Cooling therapy for mild traumatic brain injury in adolescents

An Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population

This study is testing if a cooling device can help young athletes aged 12-21 recover better from mild brain injuries they got while playing sports.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 12 Years to 21 Years
• Sex: All
• Sponsor: TecTraum Inc. (Industry-sponsored)
• Locations: 2 sites (Ann Arbor, Michigan and 1 other locations)
• Trial ID: NCT06929923 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Pro-2-Cool device, which provides non-invasive cooling to the head and neck, in adolescents aged 12-21 who have sustained a mild traumatic brain injury (mTBI) during sports activities. It is a multi-center, prospective, randomized, non-blinded, dual-arm comparator study enrolling up to 72 patients, with half receiving the cooling treatment and the other half serving as a control group. The goal is to determine if this cooling therapy can improve recovery outcomes for young athletes after mTBI.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-21 who have recently been diagnosed with a mild traumatic brain injury from sports activities.

Not a fit: Patients who have been cleared to return to play or who have sustained a more serious traumatic brain injury will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery times and outcomes for adolescents suffering from mild traumatic brain injuries.

How similar studies have performed: While the use of cooling therapies in brain injury is an emerging field, this specific approach using the Pro-2-Cool device has not been extensively tested in prior studies.

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

Where this trial is running

Ann Arbor, Michigan and 1 other locations

• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Akron Children's Hospital — Akron, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Brian Reilly, MD — Children's Hospital Medical Center of Akron
• Study coordinator: John Zak, MD, MBA

Conditions Mild Traumatic Brain Injury; Non-invasive hypothermic therapy