Do cooler heads prevail? A study using the PolarCap System shows cooling treatment results in shorter recovery time

Nov 14

By Melissa Sodko. This article was initially published in our Concussion Update newsletter; please consider subscribing.

A clinical trial published in the Journal of Neurotrauma found that Swedish male elite ice hockey players using the PolarCap System immediately following a sports-related concussion (SRC) returned to play (RTP) significantly sooner. Niklas Marklund et al. note, “An exercise-induced elevation of core body temperature is associated with increased brain temperature that may accelerate secondary injury processes following SRC, and exacerbate the brain injury.”

The PolarCap System cools the head and neck and is intended for use “for a minimum of 45 minutes directly after a diagnosed concussion.” The study findings indicate beneficial effects of this non-invasive treatment. A PolarCool press release also noted that players treated with the PolarCap showed “an immediate relief of symptoms.”

The current study, an extension of the pilot study Concussion, 2021, was expanded to 19 male elite Swedish ice hockey teams over five seasons (2016-2021). The study included 132 male elite ice hockey players (mean age 26) whose concussions occurred during practice or gameplay.

For the intervention group, 61 players with SRCs were cooled (treated) with the PolarCap System and the standard SRC management. The PolarCap System is a patented silicon-based head cap consisting of two cooling plates and an isolating cover covering the head and neck, allowing cooling of the cervical arteries. For the control group, 71 players with SRC received standard SRC management. The median time to start head-neck cooling was 10 minutes, and the median duration of cooling was 45 minutes. Findings show time for RTP was 9 days in the cooled (treated) group and 13 days in the control group. Notably, the percentage of players that did not RTP after 3 weeks was 7% among cooled (treated) players compared to 30% among non-cooled players, a difference of 80% in favor of the cooled (treated) group.

The study’s limitations include a lack of randomization to intervention and control groups and a lack of a sham intervention. According to PolarCool press release, the company is submitting a request to the FDA for a De Novo classification, “which provides a marketing pathway” and provides “reasonable assurance of safety and effectiveness for the intended use.”