Brain InjuriesNCT04919707
Youth Soccer Header Study
A study testing Header Session and MRI Session in people with Brain Injuries, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study aims to establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Header Session and MRI Session
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 20 Dec 2021
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 12-13 or 16-18 years
- Currently participating in organized interscholastic or club soccer
- No active musculoskeletal injury that limits full participation in soccer activities
Who cannot join
- 14-15 year old are not eligible
- History of prior concussion or other head injury
- History of prior cervical spine injury
- Potential participants who can not participate in the MRI scan will be excluded
- Pregnancy or possible pregnancy (one reason for MRI exclusion)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
About this study
Official title: Evaluation of Head Kinematics, Force-strain Models, and Correlation of MRI Markers With Neurocognitive Testing in Youth Soccer Heading
This study aims to establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months.
Read the detailed description
Despite the large popularity of soccer worldwide and in the US, the majority of research on sport-related head impacts has been concentrated in male American football players using head-impact measurement sensors in instrumented football helmets. The limited research in soccer players likewise has focused on males, particularly those playing at an elite level, such as collegiate or professional. Unfortunately there is a paucity of data on youth soccer athletes in regards to how these younger players actually head the ball and what forces they experience. Measurement of head impacts is essential to further understanding the potential risks associated with heading in youth soccer, and to further inform rule or policy changes that limit head impact exposure in these younger age groups.
Specific Aim: Establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks.
In this study, age-and sex-specific force strain models will be validated using a study of soccer headers under controlled conditions. Youth soccer players in 6th-12th grade will be recruited to participate in a header training session while wearing motion sensor headbands. All children will undergo MRI scanning and baseline assessment of neurocognitive function, psychological health, and academic aptitude and performance. Participant-specific finite element models will be created from MRI scans, and principle tissue strains will be determined based on head motion profiles during soccer headers and compared between age- and sex-specific groups.
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. MRI scans will be obtained in all participants, and individualized and population averaged (to reduce computational burden), whole brain tractographs will be created. New participants-specific finite element models will be generated using geometry-adaptive mesh morphing techniques to match the head morphology of each subject using a baseline FE head model (to reduce model development time). The linear and angular acceleration histories obtained from the pre- and post-training soccer heading tasks will be applied directly to the FE models to simulate the head motion of each participant. The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session. This analysis will provide insight into the effect of age and training on improving heading techniques and reducing the risk of injury.
- Conditions
- Brain Injuries
- Being tested
- Header Session, MRI Session
- Keywords
- soccer, concussion, sports injuries
- Medical subject headings
- Brain Injuries, Brain Concussion, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Header SessionBehavioural
Participant fit with commercially available Storelli ExoShield Head Guard that has been fit with head impact sensors; participant completes a set of basic standing header tasks which mimic the types of purposeful heading anticipated to occur in actual play in soccer practice and games.
MRI SessionProcedure or surgery
Scanning will include high resolution T1w imaging for 3-dimensional structural analyses, DTI and resting-state MRI for assessment of structural and functional brain network connectivity, as well as susceptibility-weighted imaging and multicomponent relaxometry to assess for microhemorrhages and myelin damage.
| Study group | Role | What they receive |
|---|---|---|
| Older Adolescent Soccer Players | Experimental | 10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI Receives: Behavioral: Header Session; Procedure: MRI Session |
| Younger Adolescent Soccer Players | Experimental | 10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI Receives: Behavioral: Header Session; Procedure: MRI Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force Strain Kinematic Model Development: Maximum Strain
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Measured: up to 2 months
Force Strain Kinematic Model Development: Minimum Principle Strain
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Measured: up to 2 months
Force Strain Kinematic Model Development: Maximum Axonal Strain
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Measured: up to 2 months
Whole brain tractography (fiber tracking) created by MRI scans
Whole brain tractographs will be created from MRI scans using Diffusion Tensor Imaging.
Measured: up to 2 months
Brain Injury Probability Map Development: Change in Tissue Strain
The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk.
Measured: During the header task session, up to 2 months
Secondary outcomes (8)
BRIEF-Monitoring Trail Making Parts A and B Score
The Trail Making Test is administered in two parts. Part A is a visual-scanning, timed task where subjects are asked to connect with lines 25 circles numbered from 1 to 25 as quickly as possible. In Part B participants are asked to connect circles containing numbers (from 1 to 13) or letters (from A to L) in an alternate numeric/alphabetical order (i.e. 1-A-2-B-3-C etc.). Errors must be corrected immediately and the sequence re-established. The TMT A-B score, calculated as the difference between TMT-A and TMT-B times, is considered a measure of cognitive flexibility relatively independent of manual dexterity.
Measured: up to 2 months
Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score
The SCAT5 contains a 22 item concussion symptom evaluation scale with score of 0-6 for each symptom and total score 0-132, higher scores indicate more severe symptoms.
Measured: up to 2 months
Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms
The SCAT5 contains a 22 item concussion symptom evaluation scale with score of 0-6 for each symptom and total score 0-132, higher scores indicate more severe symptoms.
Measured: up to 2 months
Patient Health Questionnaire (PHQ-9) Score
The PHQ-9 has 9 items with 0-3 scale for 0-27 total score. Higher score indicates greater level of depression. Scores of 0-4, 5-9, 10-14, 15-19 and >20 correspond to minimal or none, mild, moderate, moderately severe symptoms.
Measured: up to 2 months
General Anxiety Disorder Scale-7 (GAD-7) Score
The GAD-7 has 7 items with 0-3 scale for 0-21 total score. Higher score indicates greater level of anxiety. Scores of 0-4, 5-9, 10-14, and 15-21 correspond to minimal or none, mild, moderate, and severe symptoms.
Measured: up to 2 months
Pediatric Quality of Life Inventory (PEDS-QL) Score
The PedsQL is a generic measure of Health-related Quality of Life. The PedsQL consists of 23 questions that measure the domains of emotional, physical, social, and school function to calculate a physical and psychosocial summary as well as total score. The total score (23 items) is a summary score of all subscale scores (total range of scores from 0-92, higher scores indicate poorer quality of life), and the psychosocial functioning score (15 items) is a summary score of the emotional-functioning (5 items), social-functioning (5 items), and school-functioning (5 items) subscale scores (total range of scores from 0-60 where higher scores indicate poorer quality of life).
Measured: up to 2 months
Deep Cervical Flexor Endurance Test (DCFET)
The subject lies supine flat on their back, tuck their chin toward their chest and lift their head and neck approximately 2.5 cm off the ground and hold that position as long as possible. The length of time is recorded in seconds, and typically is 45-60 sec.
Measured: up to 2 months
Y Balance Test (YBT)
Leg length is measured (cm). The test consists of a centralized stance platform and three pipes connected with the platform. The pipes represent AT (Anterior), PM (Posterior Medial), and PL (Posterior Lateral) reach directions and are marked in 1.0-cm increments for measurement purposes. All pipes are equipped with a moveable reach indicator. During the testing procedure, subjects stand with one leg on the centralized platform and are instructed to reach with the other leg as far as possible in the AT, PM, and PL directions while maintaining balance. Each subject will perform three practice trials followed by three data collection trials per leg. Starting with the AT reach direction while standing on the right leg followed by standing on the left leg, this protocol is then replicated for the PM and PL directions.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start16 Aug 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Alison Brooks, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919707
- Sponsor's protocol ID
- 2021-0048
- Other IDs
- A536110, SMPH/ORTHO&REHAB/ORTHO, Protocol Version 4/26/2021
- Status last verified
- Jan 2022
- First submitted
- 25 May 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Head Kinematics, Force-strain Models, and Correlation of MRI Markers With Neurocognitive Testing in Youth Soccer Heading
- ClinicalTrials.gov ID
- NCT04919707
- Acronym / sponsor ID
- 2021-0048
- Conditions
- Brain Injuries
- Keywords
- soccer, concussion, sports injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 9 Jun 2021 (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 establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months.
Detailed description
Despite the large popularity of soccer worldwide and in the US, the majority of research on sport-related head impacts has been concentrated in male American football players using head-impact measurement sensors in instrumented football helmets. The limited research in soccer players likewise has focused on males, particularly those playing at an elite level, such as collegiate or professional. Unfortunately there is a paucity of data on youth soccer athletes in regards to how these younger players actually head the ball and what forces they experience. Measurement of head impacts is essential to further understanding the potential risks associated with heading in youth soccer, and to further inform rule or policy changes that limit head impact exposure in these younger age groups.
Specific Aim: Establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks.
In this study, age-and sex-specific force strain models will be validated using a study of soccer headers under controlled conditions. Youth soccer players in 6th-12th grade will be recruited to participate in a header training session while wearing motion sensor headbands. All children will undergo MRI scanning and baseline assessment of neurocognitive function, psychological health, and academic aptitude and performance. Participant-specific finite element models will be created from MRI scans, and principle tissue strains will be determined based on head motion profiles during soccer headers and compared between age- and sex-specific groups.
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. MRI scans will be obtained in all participants, and individualized and population averaged (to reduce computational burden), whole brain tractographs will be created. New participants-specific finite element models will be generated using geometry-adaptive mesh morphing techniques to match the head morphology of each subject using a baseline FE head model (to reduce model development time). The linear and angular acceleration histories obtained from the pre- and post-training soccer heading tasks will be applied directly to the FE models to simulate the head motion of each participant. The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session. This analysis will provide insight into the effect of age and training on improving heading techniques and reducing the risk of injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Adolescent Soccer Players | Experimental | Behavioral: Header Session, Procedure: MRI Session10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI |
| Younger Adolescent Soccer Players | Experimental | Behavioral: Header Session, Procedure: MRI Session10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 12-13 or 16-18 years
- Currently participating in organized interscholastic or club soccer
- No active musculoskeletal injury that limits full participation in soccer activities
Key exclusion criteria (5 listed)
- 14-15 year old are not eligible
- History of prior concussion or other head injury
- History of prior cervical spine injury
- Potential participants who can not participate in the MRI scan will be excluded
- Pregnancy or possible pregnancy (one reason for MRI exclusion)
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 |
|---|---|---|
| Header SessionParticipant fit with commercially available Storelli ExoShield Head Guard that has been fit with head impact sensors; participant completes a set of basic standing header tasks which mimic the types of purposeful heading anticipated to occur in actual play in soccer practice and games. | Behavioural | Older Adolescent Soccer Players, Younger Adolescent Soccer Players |
| MRI SessionScanning will include high resolution T1w imaging for 3-dimensional structural analyses, DTI and resting-state MRI for assessment of structural and functional brain network connectivity, as well as susceptibility-weighted imaging and multicomponent relaxometry to assess for microhemorrhages and myelin damage. | Procedure or surgery | Older Adolescent Soccer Players, Younger Adolescent Soccer Players |
Primary outcome
Force Strain Kinematic Model Development: Maximum Strain
Time frame: up to 2 months
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Force Strain Kinematic Model Development: Minimum Principle Strain
Time frame: up to 2 months
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Force Strain Kinematic Model Development: Maximum Axonal Strain
Time frame: up to 2 months
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Whole brain tractography (fiber tracking) created by MRI scans
Time frame: up to 2 months
Whole brain tractographs will be created from MRI scans using Diffusion Tensor Imaging.
Brain Injury Probability Map Development: Change in Tissue Strain
Time frame: During the header task session, up to 2 months
The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk.
8 secondary outcomes
BRIEF-Monitoring Trail Making Parts A and B Score
Time frame: up to 2 months
Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score
Time frame: up to 2 months
Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms
Time frame: up to 2 months
Patient Health Questionnaire (PHQ-9) Score
Time frame: up to 2 months
General Anxiety Disorder Scale-7 (GAD-7) Score
Time frame: up to 2 months
Pediatric Quality of Life Inventory (PEDS-QL) Score
Time frame: up to 2 months
Deep Cervical Flexor Endurance Test (DCFET)
Time frame: up to 2 months
Y Balance Test (YBT)
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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.
M Alison Brooks, MD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Header Session and MRI Session in people with Brain Injuries, run by University of Wisconsin, Madison at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jan 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Force Strain Kinematic Model Development: Maximum Strain (time frame: up to 2 months). The study lists 5 primary outcomes in all. 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 4 Jan 2022.