NCT03165968

Suspended

Test and Evaluation of Non-Invasive Neuro-Assessment Devices...

Uniformed Services University of the Health Sciences Source

Uniformed Services University of the Health Sciences

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

MEM 91-2714

Study Type

observational

Estimated enrollment

150

Locations

1 country

Sites

2

Timeline

Study Start

February 22, 2018

Actual (reported)

Primary Completion

September 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: suspended
Estimated enrollment: 150 participants
Study completion date: September 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 2 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 9, 2017
Actual (reported)
First Posted
May 24, 2017
Actual (reported)
Study Start
February 22, 2018
Actual (reported)
Primary Completion
September 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 11, 2021
Status Verified: May 2021
Last Update Submitted: May 7, 2021

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-PASDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-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).

Sponsors & Collaborators

Uniformed Services University of the Health Sciences
US federal agencylead
U.S. Army Medical Research and Development Command
US federal agencycollaborator

Study Sites (2)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

The Citadel - Military College of South Carolina

Charleston, South Carolina, 29409, United States

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

Actual (reported)

Primary Completion

September 30, 2022

Estimated (date passed)

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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)

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing: Will share

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03165968
Data provider: ClinicalTrials.gov
Source updated: 2021-05-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:23 UTC

Locations

US(2)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations