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

NCT03165968 | Suspended FDA Device

• 1 other identifier: MEM 91-2714
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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). 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

Outcome Measures

Primary Outcomes (1)

• Reliability of NKI i-PAS signals across three separate visits

  The NKI i-PAS device should provide similar signals each time a healthy control participant is tested.

  Three measures over Four weeks (First visit; Second visit 2-6 days later; Third visit 4 weeks after first visit

Interventions

Neuro Kinetics, Inc, i-PAS DEVICE

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy control population

You may qualify if:

• 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 (SF-36).
• A normalized Global Severity Scale of less than or equal to 65 on the Symptom Checklist-90-Revised and subscale scores less than the cut scores indicating significant pathology.

You may not qualify if:

• A TBI positive event as determined by the DVBIC (Defense and Veterans Brain Injury Center) Three Question Screening Tool.
• Any history of seizures or CNS tumors
• A normalized Global Severity Scale of more than 65 on the Symptom Checklist-90-Revised. Any subscale score indicating significant pathology
• Scores greater than one standard deviation from the mean on all eight sections of the Short Form 36 (SF-36)

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

The Citadel - Military College of South Carolina

Charleston, South Carolina, 29409, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Traumatic Injury Research Program

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 24, 2017
• Study Start: February 22, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)