Minnesota Healthy Brain Initiative

Hennepin Healthcare

Status: Completed

Conditions: Cognitive Ability, General

Study type: Observational

Funder types: Other

Identifiers

NCT02881788

HSR 16-4185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 690 patients

Sex: All

Ages: 4 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

690 participants in 3 patient groups

Traumatic Brain injury

Description:

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

Description:

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

Description:

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.