Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD: Neurokinetics, Inc, iPAS (NINADiPAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03465995
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : February 13, 2020
The Citadel, The Military College of North Carolina
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Post Traumatic Stress Disorder Device: NKI i-PAS Diagnostic Protocol

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD: Neurokinetics, Inc, iPAS
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Group/Cohort Intervention/treatment
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.
Device: 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 Measures :
  1. Unit performance reliability [ Time Frame: Total participant time burden for the study is roughly 2 hours over the course of 5 weeks. ]
    Due to the non-interventional nature of this study, no outcome data will be collected or tracked. A database of baseline performance profiles will be developed for a group of healthy research participants. The ultimate outcome of this study is a determination of reliability for the device.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Students of the The Citadel, South Carolina.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03465995

Layout table for location contacts
Contact: Dmitry Mirochnitchenko 3018168462
Contact: David Keyser, PhD 3012953467

Layout table for location information
United States, South Carolina
The Citadel Recruiting
Charleston, South Carolina, United States, 29409
Contact: Dena P Garner, Ph.D.    843-953-5060   
Contact: Christopher J Sole, Ph.D.    843-953-6386   
Principal Investigator: Dena P Garner, Ph.D.         
Sub-Investigator: Christopher J Sole, Ph.D.         
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
The Citadel, The Military College of North Carolina

Layout table for additonal information
Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine Identifier: NCT03465995    
Other Study ID Numbers: MEM 91-2714
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders