Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS (NINADiPAS)
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|ClinicalTrials.gov Identifier: NCT03165968|
Recruitment Status : Suspended (COVID19 epidemic, and institutional guidelines for halt of recruitment during epidemic)
First Posted : May 24, 2017
Last Update Posted : June 1, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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 :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
- Device: Neuro Kinetics, Inc, i-PAS
This is a test of i-PAS device reliability only.
- 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.
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
|United States, Maryland|
|Uniformed Services University of the Health Sciences|
|Bethesda, Maryland, United States, 20814|
|United States, South Carolina|
|The Citadel - Military College of South Carolina|
|Charleston, South Carolina, United States, 29409|