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

Tracking Information
First Submitted Date August 24, 2016
First Posted Date August 29, 2016
Last Update Posted Date October 19, 2020
Actual Study Start Date August 1, 2016
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Minnesota Healthy Brain Initiative
Official Title Not Provided
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition Cognitive Ability, General
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2020)
690
Original Estimated Enrollment
 (submitted: August 24, 2016)
2000
Actual Study Completion Date June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02881788
Other Study ID Numbers HSR 16-4185
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hennepin Healthcare Research Institute
Study Sponsor Hennepin Healthcare Research Institute
Collaborators Hennepin County Medical Center, Minneapolis
Investigators
Principal Investigator: Uzma Samadani, MD, PHD Hennepin County Medical Center, Minneapolis
Principal Investigator: Thomas Bergman, MD Hennepin County Medical Center, Minneapolis
PRS Account Hennepin Healthcare Research Institute
Verification Date October 2020