CClinicalTrials.gg
CompletedNCT02881788Updated Oct 19, 2020

Minnesota Healthy Brain Initiative

An observational study in Cognitive Ability, General, sponsored by Hennepin Healthcare Research Institute. Completed. Open to participants aged 4 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Hennepin Healthcare Research Institute · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
690
Ages
4 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Ability, General
03

In context

Lead sponsor

Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 100 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
690 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and 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.

06

What researchers measure

Primary outcomes

  1. Eyetracking

    The subject will complete a non-invasive eye tracking assessment. Our camera will follow the movement of their eye to assess the patterns made.

    Time frame: 0-1 yr

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02881788
Lead sponsor
Hennepin Healthcare Research Institute
Collaborators
Hennepin County Medical Center, Minneapolis
Responsible party
Sponsor
First posted
Aug 29, 2016
Start date
Aug 1, 2016
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Oct 19, 2020

Study contacts

Uzma Samadani, MD, PHD
principal investigator · Hennepin County Medical Center, Minneapolis
Thomas Bergman, MD
principal investigator · Hennepin County Medical Center, Minneapolis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion