Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout- Protocol for an Exploratory Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Region Skane
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight.
Study Overview
Brief Summary
Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female elite boxers ≥18 years old
- •Cleared for participation by the medical staff of the Swedish Boxing Association.
- •Informed consent by each participant prior to the competitive event
- •No boxing fights or match sparring during the initial 6 days after their last boxing fight
- •Signed informed consent.
Exclusion Criteria
- •>40 years old or <18 years old
- •Participation in competitive fights, match-sparring or any training causing additional head impacts during the first six post-fight days after being included in the study.
- •History of autoimmune neurological diseases or a neurodegenerative disorder.
- •History of previous traumatic brain injury resulting in an intracranial haemorrhage.
Arms & Interventions
Boxers
Intervention: PolarCap System (Device)
Controls
Outcomes
Primary Outcomes
Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight.
Time Frame: 6 days
NFL (Neurofilament light), GFAP (Glial fibrillary acidic protein)
Secondary Outcomes
- Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5).(6 days)