Pro-2-Cool Pivotal Trial II
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Concussion, Mild
In brief
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.
Key facts
- Study ID
- NCT06929923
- Run by
- TecTraum Inc.
- People needed
- 66
- Starts
- 2025-02-20
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females, 13-21 years of age
- 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
- Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
- Post-Concussion Symptom Scale Score minimum of 15
- Initial provider visit is within 7 days of injury
- 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.
- Has informed consent obtained per protocol and as required per Institutional Review Board
You may not qualify if…
- Age < 13 years or > 21 years
- Inability to understand the study requirements or provide informed consent
- Cleared to return to play during initial visit
- Prior participation in a Pro2Cool Clinical Study
- 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
- Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms
- Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
- 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
- Known brain mass, intracranial hemorrhage, skull fracture
- Scalp abnormalities including laceration or bleeding
- Presence of ventriculoperitoneal (VP) shunt
- Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
- Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines
- Known or disclosed pregnancy or breast-feeding
- Sustains another head or neck injury at the time of concussive injury which requires medical treatment
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Akron Children's Hospital — Akron, Ohio, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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