Oculomotor Function Testing in Acute Concussion
1 other identifier
observational
120
1 country
1
Brief Summary
This is a prospective longitudinal study which aims to compare oculomotor function and visual scanning behaviour (VSB) of participants who suffered concussion with healthy controls with no concussion. This study also aims to investigate the pattern of change in oculomotor function and visual scanning behaviour (VSB) in the participants over a 6-month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedSeptember 25, 2019
September 1, 2019
2.1 years
March 21, 2019
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
self-paced saccade
Number of self paced saccadic eye movements in 60 seconds
2 years
Study Arms (2)
Concussion Group
Participants (age group 18-60) who presents to the emergency department in the University Health Network within 7 days of concussion
Healthy Controls Group
Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.
Eligibility Criteria
100 participants who suffered concussions and present to the emergency department in the University Health Network within 7 days of concussion will be compared with 20 healthy volunteers who have no history of concussions.
You may qualify if:
- Participants (age group 18-60) who present to the emergency department in the University Health Network within 7 days of concussion
You may not qualify if:
- Age less than 18
- Any other neurological disorder (e.g. seizures)
- Any systemic illness known to affect the brain (e.g. diabetes and lupus)
- History of major psychiatric disorder (e.g. bipolar, schizophrenia)
- History of known developmental disorders (e.g. attention deficit disorder, dyslexia)
- Any lesion detected by MRI prior to the study
- Any previous vision disorder that prevents the participant from performing the self-paced saccade task
- Any brain injury more severe than concussion
- Controls:
- Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.
- Healthy Controls:
- Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Canadian Concussion Centre, Toronto Western Hospital, University Health Network
Toronto, Ontario, M6J 3S3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Carmela Tartaglia, M.D.
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Marion and Gerald Soloway Chair in Brain Injury and Concussion Research Associate Professor, University of Toronto
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 27, 2019
Study Start
March 1, 2019
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
September 25, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share