Pro-2-Cool Pivotal Trial II (NCT06929923)
A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population
🩺 Plain-English Summary (8th-Grade Level)
This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.
Who can join: Review the eligibility criteria below.
Location: University of Michigan — Ann Arbor, Michigan
Age range: 13 Years to 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- University of Michigan — Ann Arbor, Michigan
- Akron Children's Hospital — Akron, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (216) 789-7676
Email: jzak@tectraum.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion — Montreal, Quebec
- Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity — Birmingham, Alabama
- Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion — Calgary, Alberta
Explore by condition: All Concussion, Mild clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.