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

Not Applicable

Recruiting

• Conditions: Selective Head and Neck Cooling; Repetitive Head Impact
• Interventions: Device: PolarCap System

• Registration Number: NCT06386484
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-02
• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boxers	PolarCap System	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden; 🇸🇪 Lund, Skane, Sweden