ConcussionNCT05562544
EEG Diagnostic for Repetitive Sub-concussive Head Impacts
An observational study of Concussion, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 13 Feb 2023
- Phase
- Observational
- 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 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Soccer players between 18 and 38 years old.
Who may be able to join
- 18 - 38 years of age.
- Have at least 1 year of experience playing soccer.
- Played soccer within the prior year.
- Head soccer ball during practice and/or games.
Who cannot join
- Subjects with a history of TBI during the prior 12 months.
- History of moderate or severe Traumatic Brain Injury (TBI).
- History of seizures.
- Medical or psychiatric history the precludes participation.
- Currently receiving treatment in another research study.
- History of a condition with vestibular, ocular, or vision dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an EEG Diagnostic for Repetitive Sub-concussive Head Impacts: A Feasibility Study
The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts.
Read the detailed description
This prospective study will investigate the potential effects of soccer ball heading on EEG and oculomotor measurements.
- Conditions
- Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heading Group only | Subjects will perform a ball-passing task using their head | |
| Kicking Group then Heading Group | Subjects will perform a ball-passing task with their foot first, then will perform a ball-passing task using their head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG Signals
Sensitivity of a machine-learning based algorithm containing changes in EEG signals and functional connectivity for distinguishing research participants who headed a soccer ball from research participants who kicked the ball. A leave-one-out cross validation approach will be used.
Measured: Baseline, 45 minutes post-heading, 24 hours post-heading
Secondary outcomes (2)
Change in Eye Tracking Parameters
Sensitivity of a model containing changes in eye tracking measurements for distinguishing research participants who headed a soccer ball from research participants who kicked the ball.
Measured: Baseline, 45 minutes post-heading, 24 hours post-heading
Change in King-Devick Testing Scores
Sensitivity of a model containing changes in King-Devick test scores for distinguishing research participants who headed a soccer ball from research participants who kicked the ball.
Measured: Baseline, 45 minutes post-heading, 24 hours post-heading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start23 Sep 2022
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Spark Neuro Inc.
- Responsible party
- Principal investigator, Todd J. Schwedt, Mayo Clinic
- Investigators
- Todd Schwedt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562544
- Sponsor's protocol ID
- 22-000669
- Status last verified
- Jun 2024
- First submitted
- 6 Sep 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an EEG Diagnostic for Repetitive Sub-concussive Head Impacts: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05562544
- Acronym / sponsor ID
- 22-000669
- Conditions
- Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Spark Neuro Inc.
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 30 Sep 2022 (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.
The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts.
Detailed description
This prospective study will investigate the potential effects of soccer ball heading on EEG and oculomotor measurements.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heading Group only | – | –Subjects will perform a ball-passing task using their head |
| Kicking Group then Heading Group | – | –Subjects will perform a ball-passing task with their foot first, then will perform a ball-passing task using their head |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Soccer players between 18 and 38 years old.
Key inclusion criteria (4 listed)
- 18 - 38 years of age.
- Have at least 1 year of experience playing soccer.
- Played soccer within the prior year.
- Head soccer ball during practice and/or games.
Key exclusion criteria (6 listed)
- Subjects with a history of TBI during the prior 12 months.
- History of moderate or severe Traumatic Brain Injury (TBI).
- History of seizures.
- Medical or psychiatric history the precludes participation.
- Currently receiving treatment in another research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in EEG Signals
Time frame: Baseline, 45 minutes post-heading, 24 hours post-heading
Sensitivity of a machine-learning based algorithm containing changes in EEG signals and functional connectivity for distinguishing research participants who headed a soccer ball from research participants who kicked the ball. A leave-one-out cross validation approach will be used.
2 secondary outcomes
Change in Eye Tracking Parameters
Time frame: Baseline, 45 minutes post-heading, 24 hours post-heading
Change in King-Devick Testing Scores
Time frame: Baseline, 45 minutes post-heading, 24 hours post-heading
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 21 Jun 2024.
- 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.
Todd Schwedt, MD principal investigator
Mayo Clinic
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, run by Mayo Clinic 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 4 inclusion and 6 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 21 Jun 2024. 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?
Change in EEG Signals (time frame: Baseline, 45 minutes post-heading, 24 hours post-heading). 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 21 Jun 2024.