Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD: Neurokinetics, Inc, iPAS (NINADiPAS)
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| ClinicalTrials.gov Identifier: NCT03465995 |
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Recruitment Status :
Recruiting
First Posted : March 15, 2018
Last Update Posted : October 10, 2019
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Traumatic Brain Injury Post Traumatic Stress Disorder | Device: NKI i-PAS Diagnostic Protocol |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 : | December 31, 2019 |
| Estimated Study Completion Date : | January 30, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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NKI iPAS Diagnostic Protocol
Research participants who qualify for this study will put on EKG leads, and then a non-invasive device called iPAS, which will record heart rate and eye tracking data while participants perform a task on the screen of the device. The testing session will not exceed 30 minutes. Participants will take a total of 3 recordings over a period of roughly 5 weeks.
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Device: NKI i-PAS Diagnostic Protocol
The NKI i-PAS: The NeuroKinetics i-PAS system is a mobile assessment device with an integrated display for eye tracking with the following properties: a head mounted display, a sampling rate of 100 frames per second, eye tracking in the horizontal, vertical and torsional axes, and pupil area measurement with a spatial resolution less than 0.1 o. The testing protocol includes: optokinetic tracking, smooth pursuit horizontal, smooth pursuit vertical, saccade random horizontal, saccade random vertical, saccade predictive horizontal, antisaccade (horizontal), self-paced saccade, saccade and reaction times, visual reaction time, auditory reaction time, gaze horizontal, light reflex, subjective visual (vertical) and subjective vertical horizontal. Several quantitative measures are computed from the data acquired in each test, and these measures are then employed in a multivariate diagnostic assessment. |
- Unit performance reliability [ Time Frame: Total participant time burden for the study is roughly 2 hours over the course of 5 weeks. ]Due to the non-interventional nature of this study, no outcome data will be collected or tracked. A database of baseline performance profiles will be developed for a group of healthy research participants. The ultimate outcome of this study is a determination of reliability for the device.
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
- 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.
Exclusion Criteria:
- 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.
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): NCT03465995
| Contact: Dmitry Mirochnitchenko | 3018168462 | dmitry.mirochnitchenko.ctr@usuhs.edu | |
| Contact: David Keyser, PhD | 3012953467 | david.keyser@usuhs.edu |
| United States, South Carolina | |
| The Citadel | Recruiting |
| Charleston, South Carolina, United States, 29409 | |
| Contact: Dena P Garner, Ph.D. 843-953-5060 garnerd1@citadel.edu | |
| Contact: Christopher J Sole, Ph.D. 843-953-6386 csole@citadel.edu | |
| Principal Investigator: Dena P Garner, Ph.D. | |
| Sub-Investigator: Christopher J Sole, Ph.D. | |
| Responsible Party: | Henry M. Jackson Foundation for the Advancement of Military Medicine |
| ClinicalTrials.gov Identifier: | NCT03465995 History of Changes |
| Other Study ID Numbers: |
MEM 91-2714 |
| First Posted: | March 15, 2018 Key Record Dates |
| Last Update Posted: | October 10, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | No |
| Pediatric Postmarket Surveillance of a Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Brain Injuries Brain Injuries, Traumatic Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Trauma and Stressor Related Disorders Mental Disorders |