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Correlation Between Changes in Measures of the Visual System and Changes in Concussion-associated Symptoms

NCT03259178 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2019-03-07

No results posted yet for this study

Summary

Sports-related concussion affect 1.6 to 3.8 million people each year in the United States. Despite increased media attention and awareness campaigns, the exact number is difficult to determine due to underreporting by athletes. The types of symptoms experienced with a concussion depend on the area of the brain that was affected. The most frequent symptoms include: headaches, cognitive difficulties, dizziness, neck pain, visual disturbances, difficulty sleeping, and fatigue.

Despite the availability of many treatment options, some patients continue to experience many symptoms - such as headaches, dizziness, visual disturbances, balance problems, sensitivity to light, and difficulties concentrating - that negatively affect school, work, and quality of life for long periods of time. All of these symptoms are similarly experienced by individuals with visual dysfunctions, such as the inability of the eyes to move together. This finding has led some to recommend a visual component in concussion management. Therefore, the purpose of this study is to determine whether changes in the results of 7 binocular vision tests (BVT) over time in patients with concussion correlate with changes in concussion symptoms. The investigators will measure 46 concussion patients aged 18 to 30 years with each of these tests and assess their concussion symptoms on up to four separate visits, which depend on when the patient's symptoms improve.

The tests the investigators will evaluate measure: 3D vision, uniform movement of the eyes, ability of the eyes to adapt to a target moving towards and/or away from the eyes, quick movements of the eyes, natural alignment of the eyes, and double vision as a target is moved towards the eyes. In addition, concussion symptoms will be measured by a standardized concussion questionnaire (SCAT3) at each visit.

The results of each BVT will be entered into a statistical model with the participant's concussion symptom score to determine if there is an association between the change in symptoms and the change in the results of the tests.

Conditions

  • Concussion; Syndrome

Sponsors & Collaborators

  • Institut National du Sport du Quebec

    collaborator UNKNOWN

  • Apexk

    collaborator UNKNOWN

  • McGill University

    lead OTHER

Principal Investigators

  • Ian Shrier, MD, PhD · McGill University

Eligibility

Min Age
16 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2018-03-01
Completion
2018-03-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259178 on ClinicalTrials.gov