Clinical Studies – PolarCap® System

Clinical Studies – PolarCap® System

Pre-clinical, cohort study of ConcussionPolarCool has recently completed the second year of a study evaluating PolarCap® System for treatment of concussion among professional ice hockey players. A total of 12 teams from the Swedish Hockey League (SHL) and HockeyAllsvenskan are included in the study. In addition, the junior and female squads of the participating teams have been included. The study examines how soon players ”return to play” after progressing through a 6-step rehab protocol, a scheduled gradual increase in brain activity during the rehabilitation period after a concussion. Each step is composed of basic rules that provides guidance for exercise amount and intensity during the rehabilitation period.The six steps are:

1: Brain Rest, 2: Light Aerobic Training, 3: Technology Training, 4: Training Without Contact,        5: Full Training, 6: Return to Match.

Results from interim reviews of this study show that players treated with PolarCap® System return to play sooner than the control group, and that the percentage of players whose return to play took 3 weeks or more was higher in the control group compared to those treated with PolarCap® System. Furthermore, none of the participants who were treated with PolarCap® System indicated that they would refuse treatment if they experienced a new concussion.

These findings are important considering that curtailed absence after brain injury due to treatment with PolarCap® System generates financial benefits for athletes, sports teams, and insurance companies. Above all, the social and health benefits consist of the potential limited neurological damage as a result of treatment with PolarCap® System.

PolarCap® System is placed in the medical rooms of the participating teams and has enabled swift treatment following a diagnosed or suspected concussion. The participants are cooled during 45-60 minutes. The study has generated positive feedback from medical teams as well as from athletes.

 

 

   

Pre-clinical study of sub-concussive repetitive head impact – PolarCool has recently completed a study targeting the potential neurodegenerative pathology that repetitive head collisions generate, and the results are currently being analyzed. The study evaluates the effect of cooling on sub-concussive brain injuries by analyzing inflammatory biomarkers from blood samples taken before and after cooling. Baseline blood samples were collected during the-preason, prior to full contact activities initiated. PolarCool intends to demonstrate that cooling with the PolarCap® System relieves symptoms of brain injury that may arise as a result of repetitive head impact. This is demonstrated by comparing the development of biomarkers from blood samples taken before and after cooling, following practice or games. The protein secreted in the brain and the blood subsequent of head trauma can be identified by inflammatory biomarkers such as Tau, Nfl, and GFAP.  The biomarkers could indicate axonal damage in the brain’s white matter areas.

Multiple PolarCap® System devcies were stationed Limhamn Griffin’s facilities at Hästhagens Idrottsplats in Malmö. During the course of study, brain cooling was applied for 60 minutes after practice or game, after which blood samples were taken from both intervention and control groups.

The study is conducted in collaboration with Skåne’s University Hospital (Region Skåne), Biomedicinskt Centrum in Lund (part of Lund University),  and Limhamn Griffins Sportklubb. The results of the study are expected to be communicated in the first quarter of 2019.