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

Status unconfirmed

Conditions studied: Traumatic Brain Injury, Post Traumatic Stress Disorder

In brief

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). DoD (United States Department of Defense) 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 NKI, Inc, (NeuroKinetics, Inc) i-PAS device using a test/re-test protocol with healthy controls. The research design is test/re-test, 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, investigators will be administering standardized self-report instruments (Standard Form 36 - SF36, and Symptom Checklist 90r, or SCL-90r), standard three-lead EKG. In addition they will administer the NKI i-PAS specific protocol as delineated by NKI.

Key facts

Study ID

NCT03465995

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

200

Starts

2018-02-22

Expected to finish

2020-09-30

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• A normalized Global Severity Scale of less than or equal to 65 on the Symptom Checklist 90-R and subscale scores less than the cut scores indicating significant pathology.

You may not qualify if…

• Traumatic brain injury positive as determined by the DVBIC 3 Question Screening Tool.
• Any history of seizures or Central Nervous System (CNS) tumors
• A normalized Global Severity Scale of more than 65 on the Symptom Checklist 90-R or any subscale score indicating significant pathology.
• Scores greater than one standard deviation from the mean on all eight sections of the Short Form 36.

Where it is running

• The Citadel — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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