Reduced Concussion Symptom Burden in Early Adolescent Athletes Using a Head-Neck Cooling Device

Area of Science:

• Sports Medicine
• Neurology
• Pediatrics

Background:

• Sports-related concussions are a significant concern in adolescent athletes.
• Standard postconcussion care has limitations in rapidly alleviating symptom severity.
• Limited data exists on novel therapeutic interventions for concussion management in this age group.

Purpose of the Study:

• To evaluate the efficacy of an investigational head-neck cooling device, Pro2cool, in reducing concussion symptom severity.
• To compare Pro2cool's effectiveness against standard postconcussion care in early adolescent athletes.
• To assess the safety profile of Pro2cool in this population.

Main Methods:

• Prospective, longitudinal, randomized trial over 28 days across six pediatric medical centers.
• Enrolled 167 athletes aged 12-19 with sports-related concussions and SCAT5 scores >7.
• Intervention group received Pro2cool therapy; control group received standard care; symptom severity assessed using SCAT5 scores at multiple time points.

Main Results:

• The Pro2cool group showed significantly greater reductions in symptom severity: 14.4% at initial visit, 25.5% at 72 hours, and 3.4% at 10 days post-treatment.
• A total of 36 adverse events were reported, with 13 linked to the device, 3 of which were moderate.
• No significant differences in demographics were noted between the cooling and standard care groups.

Conclusions:

• Head and neck cooling using Pro2cool is effective in managing concussion symptoms in adolescent athletes.
• The Pro2cool device demonstrated a favorable safety profile in this study population.
• This research provides crucial data on a novel therapeutic approach for concussion management in a previously understudied age group.