Concussion, BrainNCT03892356
Oculomotor Function Testing in Acute Concussion
An observational study of Concussion, Brain, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Concussion, Brain
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: 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.
Who may be able to join
- Participants (age group 18-60) who present to the emergency department in the University Health Network within 7 days of concussion
- 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.
Who cannot join
- 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
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- 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:
- All exclusion criteria mentioned above for patients plus any history of concussions
Trial locations and contacts
1 site in 1 country.
Carmela Tartaglia, M.D. contact
Canada1 site, 1 recruiting
- Recruiting
Canadian Concussion Centre, Toronto Western Hospital, University Health Network
Toronto, Ontario, M6J 3S3
Mozhgan Khodadadi, MA, 416-603-5800 ext. 4025, Mozhgan.Khodadadi@uhn.ca
Maria C Tartaglia, M.D
About this study
Official title: Oculomotor Function Testing in Patients Who Suffered Concussions
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.
Read the detailed description
Primary Objective
- 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
- Concussion, Brain
- Keywords
- Concussion, Oculomotor function
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-paced saccade
Number of self paced saccadic eye movements in 60 seconds
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Mar 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892356
- Sponsor's protocol ID
- 18-6196
- Status last verified
- Sep 2019
- First submitted
- 21 Mar 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculomotor Function Testing in Patients Who Suffered Concussions
- ClinicalTrials.gov ID
- NCT03892356
- Acronym / sponsor ID
- 18-6196
- Conditions
- Concussion, Brain
- Keywords
- Concussion, Oculomotor function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Participants (age group 18-60) who present to the emergency department in the University Health Network within 7 days of concussion
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
self-paced saccade
Time frame: 2 years
Number of self paced saccadic eye movements in 60 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmela Tartaglia, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mozhgan Khodadadi, MA (416-603-5800 ext. 4025, Mozhgan.Khodadadi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-paced saccade (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.