Concussion (Diagnosis)DRAK-CARENCT07341880
Longitudinal Monitoring of Head Impacts in Elite Junior Ice Hockey
An observational study of Concussion (Diagnosis) and Sport-related Concussion, run by University Hospital, Caen at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion (Diagnosis), Sport-related Concussion, Hockey Player
- What is being tested?
- Head impact monitoring, Heart rate variability monitoring and Dual-task cognitive and motor assessment
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of licensed junior ice hockey players from the Hockey Club of Caen, competing in the U15 and U18 categories. These athletes regularly participate in competitive games and practices throughout the season and represent a cohort of developing players exposed to repeated head impacts in a real-world sports setting.
Who may be able to join
- Licensed athletes from the Hockey Club of Caen, playing in the U15 or U18 teams.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Head impact monitoring, Heart rate variability monitoring, Dual-task cognitive and motor assessment
- Medical subject headings
- Brain Concussion, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head impact monitoringDevice
Players wear a helmet-mounted sensor (Bearmind) during games and practices to record and quantify head impacts.
Heart rate variability monitoringOther
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 assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Head impact monitoring; Other: Heart rate variability monitoring; Other: Dual-task cognitive and motor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head impact exposure
Head impacts will be recorded using the Bearmind helmet-mounted sensor during all games and practices over the competitive season.
Measured: Continuously throughout one full competitive season during all games and practices (up to 9 months)
Secondary outcomes (3)
Heart rate variability (HRV) using a 12-minute protocol
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.
Measured: 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.
Dual-task cognitive and motor performance
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.
Measured: 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.
Sport Concussion Assessment Tool (SCAT6) score
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.
Measured: At baseline, and at 1 day and 4 days post-injury following a diagnosed concussion or severe head impact.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start3 Sep 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joffrey DRIGNY, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341880
- Sponsor's protocol ID
- DRAK-CARE
- Acronym
- DRAK-CARE
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Head Impacts in Elite Junior Ice Hockey
- ClinicalTrials.gov ID
- NCT07341880
- Acronym / sponsor ID
- DRAK-CARE / DRAK-CARE
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Jan 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Hockey Players | – | Device: Head impact monitoring, Other: Heart rate variability monitoring, Other: Dual-task cognitive and motor assessmentElite 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of licensed junior ice hockey players from the Hockey Club of Caen, competing in the U15 and U18 categories. These athletes regularly participate in competitive games and practices throughout the season and represent a cohort of developing players exposed to repeated head impacts in a real-world sports setting.
Key inclusion criteria (1 listed)
- Licensed athletes from the Hockey Club of Caen, playing in the U15 or U18 teams.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Head impact monitoringPlayers wear a helmet-mounted sensor (Bearmind) during games and practices to record and quantify head impacts. | Device | Young Hockey Players |
| Heart rate variability monitoringPlayers 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. | Other | Young Hockey Players |
| Dual-task cognitive and motor assessmentPlayers 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. | Other | Young Hockey Players |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion (Diagnosis) and Sport-related Concussion, run by University Hospital, Caen at 1 site in France.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head impact exposure (time frame: Continuously throughout one full competitive season during all games and practices (up to 9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.