- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341880
Longitudinal Monitoring of Head Impacts in Elite Junior Ice Hockey (DRAK-CARE)
This study aims to better understand how head impacts during ice hockey affect the brain and body, especially in young athletes. Even when players do not show clear signs of concussion, these repeated impacts may cause subtle changes in the brain's structure and in how the body regulates basic functions, such as heart rhythm and attention.
This study will follow elite junior ice hockey players over the course of one full season to better understand the effects of repeated head impacts. Using a small helmet sensor (Bearmind) and video analysis, researchers will record and analyze every head impact that occurs during games and practices.
Three times during the season - before, mid-season, and after - players will complete assessments of heart rate variability (using Polar H10 monitors) and a dual-task test that measures attention and coordination.
After any diagnosed concussion, players will be reassessed with both heart rate variability and dual-task testing at 3 days post-injury. Following that, dual-task testing alone will be repeated every 3 days until return to sport. Players who experience a severe head impact, as detected by the helmet sensor, will also be evaluated 3 days after the impact with both heart rate variability and dual-task testing, even if no concussion symptoms are present.
By combining these measures, the study aims to detect early physiological and cognitive changes following head impacts, improve understanding of sub-concussive effects, and support better prevention and management strategies for young athletes.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Normandy
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Caen, Normandy, France
- Centre Hospitalo-Universitaire de Caen Normandie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Licensed athletes from the Hockey Club of Caen, playing in the U15 or U18 teams.
Exclusion Criteria:
- Inability of the participant or their legal representative to receive study information or comply with study requirements.
- Participant or legal representative cannot be reached (in person, by phone, or by email) during the sports season.
- Refusal of the participant or their legal representative to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Young Hockey Players
Elite junior ice hockey players will be monitored over one full season.
Each player will wear a helmet sensor (Bearmind) to record head impacts.
Heart rate variability (Polar H10) and dual-task tests will be conducted pre-, mid-, and post-season.
After any concussion, both measures will be repeated at 3 days post-injury, with dual-task testing every 3 days until return to sport.
Following a severe head impact, assessments will occur 3 days post-impact.
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Players wear a helmet-mounted sensor (Bearmind) during games and practices to record and quantify head impacts.
Players wear a Polar H10 heart rate monitor to measure heart rate variability at designated times during the season.
HRV is assessed pre-, mid-, and post-season, and again 3 days after a diagnosed concussion or sever head impact to evaluate autonomic nervous system responses.
Players perform a dual-task test combining cognitive and motor activities while wearing a chest-mounted sensor to capture movement and performance metrics.
Assessments are conducted pre-, mid-, and post-season, 3 days after a concussion or severe impact , and every 3 days until return to sport after a concussion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Head impact exposure
Time Frame: Continuously throughout one full competitive season during all games and practices (up to 9 months)
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Head impacts will be recorded using the Bearmind helmet-mounted sensor during all games and practices over the competitive season.
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Continuously throughout one full competitive season during all games and practices (up to 9 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart rate variability (HRV) using a 12-minute protocol
Time Frame: At baseline, at mid-season (14 weeks from baseline), at end of season (up to 9 months from baseline), and within 5 days following a diagnosed concussion or severe head impact.
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HRV will be measured with the Polar H10 monitor during a standardized 12-minute protocol including three phases: resting (5 min), standing (5 min), and isometric contraction (2 min).
Measures will assess autonomic nervous system responses at baseline, mid-season, post-season, and post-injury.
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At baseline, at mid-season (14 weeks from baseline), at end of season (up to 9 months from baseline), and within 5 days following a diagnosed concussion or severe head impact.
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Dual-task cognitive and motor performance
Time Frame: At baseline, at mid-season (14 weeks from baseline), at end of season (up to 9 months from baseline), and within 5 days following a diagnosed concussion or severe head impact.
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A dual-task test combining cognitive and motor activities will be performed while players wear a chest-mounted sensor to capture movement accuracy and reaction metrics.
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At baseline, at mid-season (14 weeks from baseline), at end of season (up to 9 months from baseline), and within 5 days following a diagnosed concussion or severe head impact.
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Sport Concussion Assessment Tool (SCAT6) score
Time Frame: At baseline, and at 1 day and 4 days post-injury following a diagnosed concussion or severe head impact.
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The Sport Concussion Assessment Tool-6 (SCAT6) will be used to evaluate concussion-related symptoms, cognitive function, and balance.
Assessments will be administered under standardized conditions to monitor baseline values and post-injury recovery.
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At baseline, and at 1 day and 4 days post-injury following a diagnosed concussion or severe head impact.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Injuries, Traumatic
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Pathologic Processes
- Craniocerebral Trauma
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Disease
- Brain Concussion
Other Study ID Numbers
- DRAK-CARE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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