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

Healthy Clinical Trial

— NINADiPAS  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03165968
• Other study ID #: MEM 91-2714
• Status: Suspended
• Start date: February 22, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2021
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences	Bethesda	Maryland
United States	The Citadel - Military College of South Carolina	Charleston	South Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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