EEG Diagnostic for Repetitive Sub-concussive Head Impacts

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05562544

Enrollment

Registered

2022-09-30

Start date

2022-09-23

Completion date

2023-02-13

Last updated

2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 38 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results