NCT07341880

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
25mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Sep 2025Jun 2028

Study Start

First participant enrolled

September 3, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

November 28, 2025

Last Update Submit

January 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Head impact exposure

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

    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

    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

    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

    At baseline, and at 1 day and 4 days post-injury following a diagnosed concussion or severe head impact.

Study Arms (1)

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.

Device: Head impact monitoringOther: Heart rate variability monitoringOther: Dual-task cognitive and motor assessment

Interventions

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.

Young Hockey Players

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

Young Hockey Players

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.

Young Hockey Players

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Licensed athletes from the Hockey Club of Caen, playing in the U15 or U18 teams.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalo-Universitaire de Caen Normandie

Caen, Normandy, France

Location

MeSH Terms

Conditions

Brain ConcussionDisease

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Consulting Physician

Study Record Dates

First Submitted

November 28, 2025

First Posted

January 14, 2026

Study Start

September 3, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations