Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minnesota Healthy Brain Initiative

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881788
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Hennepin County Medical Center, Minneapolis
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Brief Summary:
Minnesota Healthy Brain Initiative will be an ongoing project that aims to increase awareness regarding brain health and its maintenance as well as increasing awareness of the impact of alcohol on brain function. In the immediate future, we hope to obtain data from a non-injured normative, diverse population represented by the state fair patrons.

Condition or disease
Cognitive Ability, General

Detailed Description:

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 690 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Group/Cohort
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.
Control
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Since we hope to gather a normative distribution, all subjects interested in participating in the study will be considered.
Criteria

Inclusion Criteria:

Males and Females Ages 4-100 All racial and ethnic origins will have an opportunity to participate

Exclusion Criteria:

Blind in one or both eyes Unable to open eyes Unable to detect light in either eye


Information from the National Library of Medicine

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


Sponsors and Collaborators
Hennepin Healthcare Research Institute
Hennepin County Medical Center, Minneapolis
Investigators
Layout table for investigator information
Principal Investigator: Uzma Samadani, MD, PHD Hennepin County Medical Center, Minneapolis
Principal Investigator: Thomas Bergman, MD Hennepin County Medical Center, Minneapolis
Additional Information:

Layout table for additonal information
Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT02881788    
Other Study ID Numbers: HSR 16-4185
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020