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Objective: To determine whether an investigational head–neck cooling device, Pro2cool, can better reduce symptom severity compared with standard postconcussion care in early adolescent athletes after a sports-related concussion. Design: Prospective, longitudinal, randomized trial design conducted over a 28-day period. Setting: Six pediatric medical centers in Ohio and Michigan. Participants: The study enrolled 167 male and female 12- to 19-year-old athletes who experienced a sports-related concussion within 8 days of study enrollment and registering a Sports Concussion Assessment Tool 5 (SCAT5) composite score.7. Interventions: Pro2cool, an investigational head–neck cooling therapy device, was applied at 2 postinjury time points compared with postconcussion standard of care only. Main Outcome Measures: Baseline SCAT5 composite symptom severity scores were determined for all subjects. Sports Concussion Assessment Tool 5 scores for concussed athletes receiving cooling treatment were analyzed across 6 independent postenrollment time points compared with subjects who did not receive cooling therapy and only standard care. Adverse reactions and participate demographics were also compared. Results: Athletes who received Pro2cool cooling therapy (n 5 79) experienced a 14.4% greater reduction in SCAT5 symptom severity scores at the initial visit posttreatment, a 25.5% greater reduction at the 72-hour visit posttreatment, and a 3.4% greater reduction at the 10-day visit compared with subjects receiving only standard care (n 5 88). Overall, 36 adverse events (increased blood pressure, decreased pulse, and dizziness) were reported, with 13 events associated with the device, of which 3 were classified as moderate in severity. Conclusions: This study demonstrates the efficacy and safety of head and neck cooling for the management of concussion symptoms in adolescent athletes of an age group for which little to no prior data are available. [ABSTRACT FROM AUTHOR]

Objective: To determine the safety and efficacy of head and neck cooling when applied up to 8 days after concussion among adolescent athletes. Design: A randomized nonblinded pilot trial. Setting: Sports Medicine Clinic in a tertiary hospital. Patients: Adolescent athletes aged 12 to 17 years diagnosed with a concussion within 1 week of injury. Interventions and Main Outcome Measures: The control group (n = 27) received standard treatment (short term brain rest), whereas the treatment group (n = 28) received standard treatment and head and neck cooling. Head and neck cooling treatment was applied to patients at the postinjury assessment visit and at 72 hours post-injury. The SCAT5 (Sport Concussion Assessment Tool) total symptom severity score was collected at postinjury assessment visit, pre- and post-treatment at 72 hours, and at 10 days, and 4 weeks post-treatment. Results: Athletes who received head and neck cooling had a faster symptom recovery (P = 0.003) and experienced significant reduction in symptom severity scores after treatment (P < 0.001). Sport type and gender did not influence the treatment outcome (P = 0.447 and 0.940, respectively). Conclusions: This pilot study demonstrates feasibility of head and neck cooling for the management of acute concussion in adolescent athletes. [ABSTRACT FROM AUTHOR]