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Completed

NCT Number: NCT05562544

EEG Diagnostic for Repetitive Sub-concussive Head Impacts

The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts.

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Key information

Conditions

Concussion Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Spark Neuro Inc.

Registry information

Official study title

Development of an EEG Diagnostic for Repetitive Sub-concussive Head Impacts: A Feasibility Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 30, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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