EEG Diagnostic for Repetitive Sub-concussive Head Impacts

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05562544

Collaborator

Spark Neuro Inc. (Industry)

Enrollment

Location

8.2

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Concussion

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 23, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Phoenix	Arizona	United States	85054

Sponsors and Collaborators

Mayo Clinic
Spark Neuro Inc.

Investigators

Principal Investigator: Todd Schwedt, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Todd J. Schwedt, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05562544

Other Study ID Numbers:

22-000669

First Posted:

Sep 30, 2022

Last Update Posted:

Jan 19, 2023

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 19, 2023