NCT02881788

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
690

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

August 24, 2016

Last Update Submit

October 15, 2020

Conditions

Cognitive Ability, General

Outcome Measures

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.

    0-1 yr

Study Arms (3)

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.

Eligibility Criteria

Age4 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Since we hope to gather a normative distribution, all subjects interested in participating in the study will be considered.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Uzma Samadani, MD, PHD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

  • Thomas Bergman, MD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 19, 2020

Record last verified: 2020-10