EEG Diagnostic for Repetitive Sub-concussive Head Impacts

April 29, 2023 updated by: Todd J. Schwedt, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This prospective study will investigate the potential effects of soccer ball heading on EEG and oculomotor measurements.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Soccer players between 18 and 38 years old.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 45 minutes post-heading, 24 hours post-heading

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eye Tracking Parameters
Time Frame: Baseline, 45 minutes post-heading, 24 hours post-heading
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.
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
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.
Baseline, 45 minutes post-heading, 24 hours post-heading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Spark Neuro Inc.

Investigators

  • Principal Investigator: Todd Schwedt, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2022

Primary Completion (Actual)

February 13, 2023

Study Completion (Actual)

February 13, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 29, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-000669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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