Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2025-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Repetitive Head Impact Selective Head and Neck Cooling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The PolarCap System consists of a high-powered portable cooling system, designed to reduce brain temperature by controlled cooling of the scalp and neck with a circulating coolant (PolarCap Coolant, PolarCool AB, Lund, Sweden). The coolant is maintained at 0°C and flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap for isolation.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Boxers

Group Type EXPERIMENTAL

PolarCap System

Intervention Type DEVICE

The PolarCap Coolant flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap to isolate the cold. Using PolarCap system to selective head and neck cooling for 45 minutes post fight in boxing.

Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PolarCap System

The PolarCap Coolant flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap to isolate the cold. Using PolarCap system to selective head and neck cooling for 45 minutes post fight in boxing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male and female elite boxers ≥18 years old
2. Cleared for participation by the medical staff of the Swedish Boxing Association.
3. Informed consent by each participant prior to the competitive event
4. No boxing fights or match sparring during the initial 6 days after their last boxing fight
5. Signed informed consent.

Exclusion Criteria

1. \>40 years old or \<18 years old
2. 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.
3. History of autoimmune neurological diseases or a neurodegenerative disorder.
4. History of previous traumatic brain injury resulting in an intracranial haemorrhage.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes