EEG Diagnostic for Repetitive Sub-concussive Head Impacts

Completed

• Conditions: Concussion

• Registration Number: NCT05562544
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-06
• Study Start: 2022-09-23
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-09-30
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in EEG Signals	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 Outcome Measures

Name	Time	Method
Change in Eye Tracking Parameters	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.
Change in King-Devick Testing Scores	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States