Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/10/2018 |
| Start Date: | February 22, 2018 |
| End Date: | December 8, 2018 |
| Contact: | Dmitry Mirochnitchenko, MS |
| Email: | dmitry.mirochnitchenko.ctr@usuhs.edu |
| Phone: | 3018168462 |
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.
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.
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)
We found this trial at
2
sites
Bethesda, Maryland 20814
Principal Investigator: Paul Rapp, Ph.D.
Phone: 301-319-8472
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Charleston, South Carolina 29409
Principal Investigator: Dena Garner, Ph.D.
Phone: 843-953-6323
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