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NCT Number: NCT07341880

Longitudinal Monitoring of Head Impacts in Elite Junior Ice Hockey

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Concussion (Diagnosis) Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Disease Head Injuries, Closed Hockey Player Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sport-related Concussion Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalo-Universitaire de Caen Normandie

Caen, Normandy, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Head impact monitoring

Device

Players wear a helmet-mounted sensor (Bearmind) during games and practices to record and quantify head impacts.

Heart rate variability monitoring

Other

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.

Dual-task cognitive and motor assessment

Other

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.

Primary outcomes

  1. Head impact exposure

    Time frame: Continuously throughout one full competitive season during all games and practices (up to 9 months)

    Head impacts will be recorded using the Bearmind helmet-mounted sensor during all games and practices over the competitive season.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie

Registry information

Acronym: DRAK-CARE

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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