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.|
|ClinicalTrials.gov Identifier: NCT03465995|
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : February 13, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03465995
|Contact: Dmitry Mirochnitchenkofirstname.lastname@example.org|
|Contact: David Keyser, PhDemail@example.com|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29409|
|Contact: Dena P Garner, Ph.D. 843-953-5060 firstname.lastname@example.org|
|Contact: Christopher J Sole, Ph.D. 843-953-6386 email@example.com|
|Principal Investigator: Dena P Garner, Ph.D.|
|Sub-Investigator: Christopher J Sole, Ph.D.|