Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
120 participants
OBSERVATIONAL
2019-03-01
2021-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
NCT03319966
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
NCT02776462
Dynamic Vision Testing and Concussion Management
NCT04837066
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
NCT01832714
Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
NCT00875589
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* To identify differences in oculomotor function and visual scanning behaviour (VSB) between participant with and without acute concussion
* To investigate patterns of change and recovery in oculomotor function and VSB in participants who suffered a concussion
Secondary Objective
• To investigate the association between the oculomotor function and concussion-related symptoms
This is a prospective longitudinal study which aims to evaluate differences in oculomotor function and visual scanning behaviour (VSB) between participants who suffered acute concussion and 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.
Health information and concussion history: After obtaining informed consents, during the first visit, participants will be asked about their health history such as past medical history, medication history, substance use history, and family history. They will also be asked about their concussion history which includes number of concussions in the past, any comorbidity with the concussions, mechanism of injury, and any change in their levels of consciousness at the time of concussion.
Self-reported outcomes: During each visit, participants will be asked on the presence or absence of concussion-related symptoms and the extent to which these symptoms affect their everyday functioning if present. The symptoms the participants will be questioned using the Rivermead Post-concussive Symptom Questionnaire (RPQ) as a standardized assessment (https://www.commondataelements.ninds.nih.gov/TBI.aspx#tab=Data\_Standards) at each visit .
Oculomotor function testing and visual scanning behaviour (VSB): During each visit, oculomotor data will be collected using Visual Attention Scanning Technology (VAST, EL-MAR Inc.). VAST is a technology that was developed to support advanced eye-tracking research application. Over the past 10 years the technology has been used in research studies in the University of Toronto, and University Health Network hospitals. Participants will be seated 65 cm from the monitor, and their binocular gaze positions will be estimated 30 times/sec with an accuracy of 0.5º in visual angle. Following a calibration procedure, the participants will be instructed to look at a series of slides presented on the monitor, and their eye positions will be recorded. The eye positions will be segmented into fixations that are linked to the displayed images. Oculomotor functions testing includes testing self-paced saccadic (SPS) eye movements, fixation, anti-saccadic eye movements. Visual scanning behaviour (VSB) will be assessed using a set of images which require patients to look at the images and match them according to the instruction at the beginning of each test.
Patients will be assessed at baseline (i.e. within 7 days of concussion) and three follow-up (f/u) visits (i.e. 1, 3, and 6 months after concussion).
Healthy controls will be assessed at baseline and one follow-up visit (i.e. 6 months after the baseline).
The entire assessment in each visit takes 30-45 minutes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Concussion Group
Participants (age group 18-60) who presents to the emergency department in the University Health Network within 7 days of concussion
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
• 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.
Exclusion Criteria
* 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:
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carmela Tartaglia
Marion and Gerald Soloway Chair in Brain Injury and Concussion Research Associate Professor, University of Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Canadian Concussion Centre, Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Carmela Tartaglia, M.D.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-6196
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.