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

May 7, 2021 updated by: Paul Rapp, Uniformed Services University of the Health Sciences

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Uniformed Services University of the Health Sciences
    • South Carolina
      • Charleston, South Carolina, United States, 29409
        • The Citadel - Military College of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy control population

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of NKI i-PAS signals across three separate visits
Time Frame: Three measures over Four weeks (First visit; Second visit 2-6 days later; Third visit 4 weeks after first visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniformed Services University of the Health Sciences

Collaborators

U.S. Army Medical Research and Development Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2018

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • MEM 91-2714

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upload to FITBIR Database NIH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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