Clinical trial NCT03165968: Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS
Official title: Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Healthy
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2017-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy control population

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.


Eligibility 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)

Primary outcomes:
measure: Reliability of NKI i-PAS signals across three separate visits
timeFrame: Three measures over Four weeks (First visit; Second visit 2-6 days later; Third visit 4 weeks after first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
city: Charleston
country: United States
facility: The Citadel - Military College of South Carolina
state: South Carolina
Study officials:
References: