Dynamic Vision Testing and Concussion Management

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

Study Overview

• Status: Recruiting
• Conditions: Head Injury; Sport Injury; Concussion, Brain
• Intervention / Treatment: Diagnostic test: Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System

Detailed Description

The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Aimie Kachingwe, Dr.; Phone Number: 818-677-4684; Email: aimie.kachingwe@csun.edu
• Study Contact Backup: Name: Margaret Roller, Dr.; Phone Number: 818-677-4684; Email: peggy.roller@csun.edu

Study Locations

• United States
  • California
    • Northridge, California, United States, 91330-8411
      • Recruiting
      • California State University, Northridge, Jacaranda Hall 1578, 1576, 1574
      • Contact: Aimie Kachingwe, Dr.; Phone Number: 818-677-4684; Email: aimie.kachingwe@csun.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Due to COVID-19 and the uncertainty of which teams will be competing during the academic year, our subject pool will potentially come from any athlete who provides consent from an equal number of men's and women's teams who are competing that semester.

Description

Inclusion Criteria:

• California State University Northridge athletes
• Participants are able to give consent to participate in the study
• Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
• Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
• Sampling of convenience on a volunteer basis

Exclusion Criteria:

• Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
• The initial 6- condition BESS score is >20 errors
• The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Condition BESS	Number of errors and time subject was able to hold position	August 15, 2021 - August 15, 2024
Gaze Stabilization Test (GST)	Maximum head velocity in degrees/second	August 15, 2021 - August 15, 2024
Dynamic Visual Acuity (DVA)	Log of minimal angle resolvable units (LogMAR). The number of lines on an eye chart that are lost with head moving (DVA) compared to the head steady condition, known as static visual acuity (SVA)	August 15, 2021 - August 15, 2024

Collaborators and Investigators

• Sponsor: California State University, Northridge
• Investigators: Principal Investigator: Aimie Kachingwe, Dr., CSUN; Principal Investigator: Margaret Roller, Dr., CSUN

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Craniocerebral Trauma; Athletic Injuries; Brain Concussion; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Imidacloprid
• Other Study ID Numbers: IRB-FY20-339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No