Clinical Trial

Test and Evaluation of Non-Invasive Neuro-Assessment Devices

Study Description

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

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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 verti ...read more on ClinicalTrials.org

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03465995

ParticipAid ID

vbm1nb