Cooling therapy for mild traumatic brain injury in adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males and females, 13-21 years of age
2. 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
3. Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
4. Post-Concussion Symptom Scale Score minimum of 15
5. Initial provider visit is within 7 days of injury
6. 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.
7. Has informed consent obtained per protocol and as required per Institutional Review Board

Exclusion Criteria:

1. Age \< 13 years or \> 21 years
2. Inability to understand the study requirements or provide informed consent
3. Cleared to return to play during initial visit
4. Prior participation in a Pro2Cool Clinical Study
5. 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
6. Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms
7. Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
8. 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
9. Known brain mass, intracranial hemorrhage, skull fracture
10. Scalp abnormalities including laceration or bleeding
11. Presence of ventriculoperitoneal (VP) shunt
12. Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
13. Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines
14. Known or disclosed pregnancy or breast-feeding
15. Sustains another head or neck injury at the time of concussive injury which requires medical treatment

Where it's running

• Akron Children's Hospital
  Akron, Ohio, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Not yet recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Brian Reilly, MD — Children's Hospital Medical Center of Akron
• Study coordinator: John Zak, MD, MBA
• Email: jzak@tectraum.com
• Phone: 216-789-7676

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.