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

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 Overview

• Status: Recruiting
• Conditions: Repetitive Head Impact; Selective Head and Neck Cooling
• Intervention / Treatment: Device: PolarCap System

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Al-Husseini, Medical doctor, phd stud; Phone Number: +46707267261; Email: ali.al-husseini@med.lu.se

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22100
      • Recruiting
      • Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden
      • Contact: Ali Al-husseini, MD, Medical doctor, PhD stud; Phone Number: +46707267261; Email: Ali.al-husseini@med.lu.se
      • Sub-Investigator: Ali Al-husseini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controls
Experimental: Boxers	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019-05463

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No