Minnesota Healthy Brain Initiative
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|ClinicalTrials.gov Identifier: NCT02881788|
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : October 19, 2020
|Condition or disease|
|Cognitive Ability, General|
We hypothesize that a non-invasive 30-minute test, requiring a subject to complete questionnaires and watch images on a TV screen, will yield information relevant to both diagnosis and prognosis of neurological state. To clarify, these tests will not produce information that would involve a diagnostic finding for the participants. We will measure eye movements under a range of visual conditions, including saccades, fixations, smooth pursuit, scan paths and optico-kinetic nystagmus
After receiving proper introduction and signing the proper consent forms, the subject will receive instructions to carry out cognitive assessments and answer verbal questionnaires. The subject will also undergo eye tracking. In order to validate the data collected by our eye-trackers, we may ask the subject to complete a non-invasive vision assessment and a breathalyzer assessment. Due to the nature of the breathalyzer assessment, we have decided not to administer the breathalyzer assessment to subjects who are under the age of 21 and/or pregnant. We also refuse to disclose the results of the breathalyzer assessment to the subject since the data will be collected only for research purposes. Subjects' eye movements will be tracked binocularly at a fixed distance from a computer monitor over a brief time period. The visual stimuli will be video clips appropriate for a general or pediatric audience. If at any point the subject becomes uncomfortable, the procedure will be aborted and can be resumed at a later time.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||690 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||1 Year|
|Actual Study Start Date :||August 1, 2016|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
Traumatic Brain injury
There will be no intervention necessary. We will analyze the eyetracking data from subjects who have sustained a traumatic brain injury. We are hoping to find patterns that may indicate a TBI in the data we collect.
Non-Traumatic Brain injury
There will be no intervention necessary. We will analyze the eyetracking data from subjects who have sustained a non-trauma related brain injury. We are hoping to find patterns that we may compare this data to subjects who have sustained a TBI as well as healthy controls.
There will be no intervention necessary. We will analyze the eyetracking data from subjects who have not recently sustained any brain injury. We are hoping to find patterns that we may compare this data to subjects who have sustained a TBI as well as subjects who have had a non-trauma related brain injury.
- Eyetracking [ Time Frame: 0-1 yr ]The subject will complete a non-invasive eye tracking assessment. Our camera will follow the movement of their eye to assess the patterns made.
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): NCT02881788
|Principal Investigator:||Uzma Samadani, MD, PHD||Hennepin County Medical Center, Minneapolis|
|Principal Investigator:||Thomas Bergman, MD||Hennepin County Medical Center, Minneapolis|