Clinical trial NCT02881788: Minnesota Healthy Brain Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Ability, General
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Hennepin County Medical Center, Minneapolis
First posted: 2016-08-29
Enrollment: 690
Sex: ALL
Minimum age (years): 4
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Eyetracking
timeFrame: 0-1 yr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Uzma Samadani, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hennepin County Medical Center, Minneapolis
name: Thomas Bergman, MD
role: PRINCIPAL_INVESTIGATOR
References: