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

Sponsor
Uniformed Services University of the Health Sciences (U.S. Fed)
Overall Status
Suspended
CT.gov ID
NCT03165968
Collaborator
U.S. Army Medical Research and Development Command (U.S. Fed)
150
2
55.2
75
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuro Kinetics, Inc, i-PAS

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS
Actual Study Start Date :
Feb 22, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Reliability of NKI i-PAS signals across three separate visits [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uniformed Services University of the Health Sciences Bethesda Maryland United States 20814
2 The Citadel - Military College of South Carolina Charleston South Carolina United States 29409

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul Rapp, Director, Traumatic Injury Research Program, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT03165968
Other Study ID Numbers:
  • MEM 91-2714
First Posted:
May 24, 2017
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of May 11, 2021