Randomized Double-Blind Study of Pro2Cool Head and Neck Cooling Therapy for Concussion in Adolescents and Young Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Pro-2-Cool head and neck cooling therapy after concussion in adolescent athletes aged 13 to 21. This study compares symptom improvements measured by the post-concussion symptom severity score between those receiving the cooling treatment and those receiving a sham cooling device. The trial is randomized, double-blinded, and includes up to 66 participants. Participants are randomly assigned to either the treatment group, which receives standard concussion care plus 30 minutes of head and neck cooling with the Pro2Cool device, or to the control group, which receives standard care plus 30 minutes with a sham cooling garment that does not provide therapeutic cooling. Both groups are monitored for side effects during the treatment session. During the study, participants are assessed for symptom changes from injury to 72 hours after treatment using the PCSS score. Researchers also track any adverse events related to the cooling therapy during this period. The total study participation lasts through the 72-hour follow-up to evaluate safety and symptom outcomes.

Pro-2-Cool Pivotal Trial II