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

Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout- Protocol for an Exploratory Randomized Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06386484
Enrollment
40
Registered
2024-04-26
Start date
2021-11-02
Completion date
2025-01-30
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repetitive Head Impact, Selective Head and Neck Cooling

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.

Interventions

DEVICEPolarCap 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.

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight.6 daysNFL (Neurofilament light), GFAP (Glial fibrillary acidic protein)

Secondary

MeasureTime frame
Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5).6 days

Countries

Sweden

Contacts

Primary ContactAli Al-Husseini, Medical doctor, phd stud
ali.al-husseini@med.lu.se+46707267261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026