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

NCT03259178 | Terminated

• 1 other identifier: ConBVT
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Binocular vision test

Outcome Measures

Primary Outcomes (1)

• Correlation between the change in 5 of the 7 BVT and only concussion symptoms that affect those particular BVTs.

  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".

  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*).

Secondary Outcomes (4)

• Associations between the total concussion symptom score and the total binocular vision test score

  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*).

• Associations between the scores for each concussion symptom and the scores for each BVT

  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*).

• Demographic variables as modifiers of the correlation between the results of the binocular vision tests and concussion symptoms.

  Demographic information and medical history will be collected at the first visit.

• Change in tests in the absence of a change in symptoms

  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*).

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead
• Institut National du Sport du Quebec: collaborator
• Apexk: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, H3G1Y6, Canada

Location

Related Publications (6)

• Campos EC, Cipolli C. Binocularity and photophobia in intermittent exotropia. Percept Mot Skills. 1992 Jun;74(3 Pt 2):1168-70. doi: 10.2466/pms.1992.74.3c.1168.

  PMID: 1501986 RESULT

• Dikmen S, Machamer J, Fann JR, Temkin NR. Rates of symptom reporting following traumatic brain injury. J Int Neuropsychol Soc. 2010 May;16(3):401-11. doi: 10.1017/S1355617710000196. Epub 2010 Mar 1.

  PMID: 20188017 RESULT

• Kerr ZY, Register-Mihalik JK, Kroshus E, Baugh CM, Marshall SW. Motivations Associated With Nondisclosure of Self-Reported Concussions in Former Collegiate Athletes. Am J Sports Med. 2016 Jan;44(1):220-5. doi: 10.1177/0363546515612082. Epub 2015 Nov 18.

  PMID: 26582799 RESULT

• Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

  PMID: 16983222 RESULT

• McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.

  PMID: 23855364 RESULT

• Ventura RE, Balcer LJ, Galetta SL. The Concussion Toolbox: The Role of Vision in the Assessment of Concussion. Semin Neurol. 2015 Oct;35(5):599-606. doi: 10.1055/s-0035-1563567. Epub 2015 Oct 6.

  PMID: 26444405 RESULT

MeSH Terms

Conditions

Brain Concussion; Syndrome

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; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Shrier, MD, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 23, 2017
• Study Start: June 8, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)