NCT06929923 · TecTraum Inc.
Pro-2-Cool Pivotal Trial II
What this study is about
This study is being conducted to determine the clinical safety and effectiveness 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
- Ann Arbor, Michigan
- Akron, Ohio
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations