NCT06929923
Pro-2-Cool Pivotal Trial II
Recruiting
NAAges 13–21InterventionalTreatmentTecTraum Inc.
~66 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Pro2Cool DeviceSham Cooling Garment Device
At a glance
Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change quantified by post-concussion symptom severity (PCSS) assessment score
Measured over Post-injury to 72-hour follow-up
Conditions
Where it's being run
3 sites across 2 statesOhio2
Michigan1
Study leadership
- Brian Reilly, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center of Akron
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Change quantified by post-concussion symptom severity (PCSS) assessment scorePost-injury to 72-hour follow-up