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

This study is currently recruiting participants.
Verified August 2017 by Ian Shrier, McGill University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03259178
First Posted: August 23, 2017
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Institut National du Sport du Quebec
Apexk
Information provided by (Responsible Party):
Ian Shrier, McGill University
  Purpose

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.


Condition
Concussion; Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between Changes in Measures of the Visual System and Changes in Concussion-associated Symptoms

Further study details as provided by Ian Shrier, McGill University:

Primary Outcome Measures:
  • Correlation between the change in 5 of the 7 BVT and only concussion symptoms that affect those particular BVTs. [ Time Frame: For each participant, there will be at least 3 milestone timepoints: M1, M2, M3. If the participant does not demonstrate significant improvement within 2 weeks, he/she will be evaluated at the 2-week mark (M*). ]

    The correlation will be evaluated from the estimated change in BVTs associated with an increase in the sum of the scores for several symptoms by one score as measured by the SCAT3.

    The correlations will be restricted to the following comparisons: (1) Convergence measured by "motor punctum proximum" versus sum of "headache, sensitivity to light, difficulty concentrating, difficulty remembering, fatigue, low energy", (2) Binocular fusion with convergence versus sum of "headache, sensitivity to light, feeling fog, don't feel right, difficulty concentrating, fatigue", (3) "Convergence fusional proximum" versus sum of "headache, blurred vision, sensitivity to light, difficulty concentrating, difficulty remembering, fatigue, feeling fog", and (4) Binocular fusion with divergence versus sum of "headache, blurred vision, sensitivity to light, fatigue".



Secondary Outcome Measures:
  • Associations between the total concussion symptom score and the total binocular vision test score [ Time Frame: For each participant, there will be at least 3 milestone timepoints: M1, M2, M3. If the participant does not demonstrate significant improvement within 2 weeks, he/she will be evaluated at the 2-week mark (M*). ]
    The association between the total concussion symptom score and the total BVT score will be estimated from the coefficients (β) of the regression model.

  • Associations between the scores for each concussion symptom and the scores for each BVT [ Time Frame: For each participant, there will be at least 3 milestone timepoints: M1, M2, M3. If the participant does not demonstrate significant improvement within 2 weeks, he/she will be evaluated at the 2-week mark (M*). ]
    The association between the total concussion symptom score and the total BVT score will be estimated from the coefficients (β) of the regression model.

  • Demographic variables as modifiers of the correlation between the results of the binocular vision tests and concussion symptoms. [ Time Frame: Demographic information and medical history will be collected at the first visit. ]
    The coefficients (β) (as estimated from the linear regression model) of each individual test will be compared across subgroups stratified by sex, level of education, use of corrective lenses, past medical history (history of concussion, depression, anxiety, attention deficit (hyperactive) disorder, migraines, and eye injury), use of medications (grouped by drug classes).

  • Change in tests in the absence of a change in symptoms [ Time Frame: For each participant, there will be at least 3 milestone timepoints: M1, M2, M3. If the participant does not demonstrate significant improvement within 2 weeks, he/she will be evaluated at the 2-week mark (M*). ]
    If there are participants who do not improve significantly, the primary analysis will be repeated on this select group of participants. Although there might not be significant improvement, there might still be some change in symptoms.


Estimated Enrollment: 46
Actual Study Start Date: June 8, 2017
Estimated Study Completion Date: March 30, 2018
Estimated Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Our target population is healthy adults aged 16 to 30 with concussion symptoms for at least 8 days and no more than 70 days.
Criteria

Inclusion Criteria:

  • Participants must be 16 years or older
  • Diagnosis of concussion by a medical doctor
  • Participants must have concussion-related symptoms lasting at least 8 days, and no more than 70 days at the time of recruitment.

Exclusion Criteria:

  • Participants with strabismus or a history of treated strabismus
  • Head trauma other than a concussion (minor head injury)
  • History of migraine or known neurologic disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259178


Contacts
Contact: Ian Shrier, MD, PhD 5142449061 ian.shrier@mcgill.ca
Contact: Stephanie Long, BA, BSc 5145126345 stephanie.long@mail.mcgill.ca

Locations
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada, H3G1Y6
Contact: Stephanie Long, BA, BSc    5145126345    stephanie.long@mail.mcgill.ca   
Principal Investigator: Ian Shrier, MD, PhD         
Sponsors and Collaborators
McGill University
Institut National du Sport du Quebec
Apexk
Investigators
Principal Investigator: Ian Shrier, MD, PhD McGill University
  More Information

Publications:
Responsible Party: Ian Shrier, Principle investigator, McGill University
ClinicalTrials.gov Identifier: NCT03259178     History of Changes
Other Study ID Numbers: ConBVT
First Submitted: August 19, 2017
First Posted: August 23, 2017
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ian Shrier, McGill University:
Binocular vision test