Minnesota Healthy Brain Initiative

Cognitive Ability, General Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881788
• Other study ID #: HSR 16-4185
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2020
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Ability, General

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Hennepin County Medical Center, Minneapolis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-1 yr