Clinical Trial

Non-Invasive Neuro-Assessment Device

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). The Department of Defense (DoD) 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 NeuroKinetics Inc (NKI), i-PAS (portable assessment system) device using a test/re-test protocol with healthy controls. The basic research design adopted here is the test/re-test paradigm 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 we will be administering standardized self-report instruments ( Short Form - 36 (SF-36) and the Symptom Checklist-90 (SCL-90r)), standard three-lead electrocardiogram. In addition we 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 - Neuro Kinetics, Inc, i-PAS

This is a test of i-PAS device reliability only.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03165968

ParticipAid ID

9aALOe