EEG Diagnostic for Repetitive Sub-concussive Head Impacts

Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562544
• Other study ID #: 22-000669
• Status: Completed
• Start date: September 23, 2022
• Est. completion date: February 13, 2023

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Concussion

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Spark Neuro Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 45 minutes post-heading, 24 hours post-heading
Secondary	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.	Baseline, 45 minutes post-heading, 24 hours post-heading
Secondary	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.	Baseline, 45 minutes post-heading, 24 hours post-heading