Repetitive Head ImpactNCT06386484
Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout
A study testing PolarCap System in people with Repetitive Head Impact and Selective Head and Neck Cooling, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Repetitive Head Impact, Selective Head and Neck Cooling
- What is being tested?
- PolarCap System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 2 Nov 2021to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- >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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden
Lund, Skåne County, 22100
Ali Al-husseini, MD, Medical doctor, PhD stud, +46707267261, Ali.al-husseini@med.lu.se
Ali Al-husseini
About this study
Official title: 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.
- Being tested
- PolarCap System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolarCap SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Boxers | Experimental | Not described Receives: Device: PolarCap System |
| Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 days
Secondary outcomes (1)
Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5).
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start2 Nov 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Repetitive Head ImpactStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386484
- Sponsor's protocol ID
- 2019-05463
- Other IDs
- 2019
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Husseini A, Tegner Y, Blennow K, Zetterberg H, Marklund N. Effects of Selective Head-and-Neck Cooling on Brain Injury-Related Biomarker Levels and Symptom Rating Following a Boxing Bout: Protocol for an Exploratory Randomized Trial. JMIR Res Protoc. 2025 Jun 16;14:e68954. doi: 10.2196/68954.
PubMed 40523276
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout- Protocol for an Exploratory Randomized Trial
- ClinicalTrials.gov ID
- NCT06386484
- Acronym / sponsor ID
- 2019-05463
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Boxers | Experimental | Device: PolarCap System |
| Controls | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolarCap SystemThe 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. | Device | Boxers |
Primary outcome
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)
1 secondary outcome
Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5).
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 40523276Al-Husseini A, Tegner Y, Blennow K, Zetterberg H, Marklund N. Effects of Selective Head-and-Neck Cooling on Brain Injury-Related Biomarker Levels and Symptom Rating Following a Boxing Bout: Protocol for an Exploratory Randomized Trial. JMIR Res Protoc. 2025 Jun 16;14:e68954. doi: 10.2196/68954.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PolarCap System in people with Repetitive Head Impact and Selective Head and Neck Cooling, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Al-Husseini, Medical doctor, phd stud (+46707267261, ali.al-husseini@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.