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Trial record 17 of 18 for:    citadel

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

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ClinicalTrials.gov Identifier: NCT03165968
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Paul Rapp, Uniformed Services University of the Health Sciences

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
Healthy Device: Neuro Kinetics, Inc, i-PAS

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Study Type : Observational
Estimated 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 : February 22, 2018
Estimated Primary Completion Date : June 7, 2018
Estimated Study Completion Date : December 8, 2018

Intervention Details:
  • Device: Neuro Kinetics, Inc, i-PAS
    This is a test of i-PAS device reliability only.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy control population
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165968


Contacts
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Contact: Dmitry Mirochnitchenko, MS 3018168462 dmitry.mirochnitchenko.ctr@usuhs.edu
Contact: Kevin Toruno, MBA 3018168465 kevin.toruno.ctr@usuhs.edu

Locations
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United States, Maryland
Uniformed Services University of the Health Sciences Not yet recruiting
Bethesda, Maryland, United States, 20814
Contact: Dmitry Mirochnitchenko, MS    301-319-8472    dmitry.mirochnitchenko.ctr@usuhs.edu   
Principal Investigator: Paul Rapp, Ph.D.         
United States, South Carolina
The Citadel - Military College of South Carolina Recruiting
Charleston, South Carolina, United States, 29409
Contact: Dena Garner, Ph.D.    843-953-6323    garnerd1@citadel.edu   
Principal Investigator: Dena Garner, Ph.D.         
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
U.S. Army Medical Research and Development Command

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Responsible Party: Paul Rapp, Director, Traumatic Injury Research Program, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT03165968     History of Changes
Other Study ID Numbers: MEM 91-2714
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upload to FITBIR Database NIH

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No