Recruiting

Neuro-Assessment Devices

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT03465995

Conditions

Traumatic Brain Injury

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

NKI i-PAS Diagnostic Protocol

Study Details

Brief summary:

The long term goal for the Traumatic Injury Research Program (TIRP) is testing of novel devices for the identification and longitudinal assessment of traumatic brain injury (TBI). DoD (United States Department of Defense) has now tasked TIRP with the test and evaluation of these devices to assess reliability and validity. The objective of this effort is to test the reliability of the NKI, Inc, (NeuroKinetics, Inc) i-PAS device using a test/re-test protocol with healthy controls.

The research design is test/re-test, with three assessments obtained on three separate visits. This will allow the assessment of reliability of both the device and the measure(s) that are computed from the input signals. Participants will be Healthy Controls (HC) as defined in the inclusion exclusion section.

In this initial study, investigators will be administering standardized self-report instruments (Standard Form 36 - SF36, and Symptom Checklist 90r, or SCL-90r), standard three-lead EKG. In addition they will administer the NKI i-PAS specific protocol as delineated by NKI.

Conditions

Traumatic Brain Injury

Post Traumatic Stress Disorder

Study ID

NCT03465995

Start date

Feb 22, 2018

Status verified date

Feb, 2020

Completion date

Sep 30, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male and female participants
  • Between 18 and 55 years old
  • In good general health. Good general health is operationalized for the purpose of this study by scores within one standard deviation of the mean in all eight sections of the short form 36.
  • A normalized Global Severity Scale of less than or equal to 65 on the Symptom Checklist 90-R and subscale scores less than the cut scores indicating significant pathology.

Exclusion Criteria:

  • Traumatic brain injury positive as determined by the DVBIC 3 Question Screening Tool.
  • Any history of seizures or Central Nervous System (CNS) tumors
  • A normalized Global Severity Scale of more than 65 on the Symptom Checklist 90-R or any subscale score indicating significant pathology.
  • Scores greater than one standard deviation from the mean on all eight sections of the Short Form 36.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

NKI iPAS Diagnostic Protocol

Research participants who qualify for this study will put on EKG leads, and then a non-invasive device called iPAS, which will record heart rate and eye tracking data while participants perform a task on the screen of the device. The testing session will not exceed 30 minutes. Participants will take a total of 3 recordings over a period of roughly 5 weeks.

Interventions

NKI i-PAS Diagnostic Protocol

The NKI i-PAS:

The NeuroKinetics i-PAS system is a mobile assessment device with an integrated display for eye tracking with the following properties: a head mounted display, a sampling rate of 100 frames per second, eye tracking in the horizontal, vertical and torsional axes, and pupil area measurement with a spatial resolution less than 0.1 o. The testing protocol includes: optokinetic tracking, smooth pursuit horizontal, smooth pursuit vertical, saccade random horizontal, saccade random vertical, saccade predictive horizontal, antisaccade (horizontal), self-paced saccade, saccade and reaction times, visual reaction time, auditory reaction time, gaze horizontal, light reflex, subjective visual (vertical) and subjective vertical horizontal. Several quantitative measures are computed from the data acquired in each test, and these measures are then employed in a multivariate diagnostic assessment.

Primary outcome measure

  • Unit performance reliability [ Time Frame: Total participant time burden for the study is roughly 2 hours over the course of 5 weeks. ]

Central Contacts and Locations

Central contacts

Dmitry Mirochnitchenko

3018168462dmitry.mirochnitchenko.ctr@usuhs.edu

David Keyser, PhD

3012953467david.keyser@usuhs.edu

Locations

The Citadel

Recruiting

Charleston, South Carolina, United States, 29409

Contacts

Dena P Garner, Ph.D.

843-953-5060garnerd1@citadel.edu

Christopher J Sole, Ph.D.

843-953-6386csole@citadel.edu

Principal Investigator:

Dena P Garner, Ph.D.

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Feb 13, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2020-02-13.