EEG Diagnostic for Repetitive Sub-concussive Head Impacts

NCT05562544 | Completed

• 1 other identifier: 22-000669
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Eye Tracking Parameters

  Baseline, 45 minutes post-heading, 24 hours post-heading

• Change in King-Devick Testing Scores

  Baseline, 45 minutes post-heading, 24 hours post-heading

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Soccer players between 18 and 38 years old.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Spark Neuro Inc.: collaborator

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Todd Schwedt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 30, 2022
• Study Start: September 23, 2022
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)