NCT03165968

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Uniformed Services University of the Health Sciences · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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). 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Neuro Kinetics, Inc, i-PAS	This is a test of i-PAS device reliability only.

Timeline

• Start date: 2018-02-22
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2017-05-24
• Last updated: 2021-05-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study