Test and Evaluation of Non-Invasive Neuro-Assessment Devi... | NCT03165968

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

NCT03165968

Sponsor

Uniformed Services University of the Health Sciences

Status

Suspended

Last Update Posted

May 11, 2021Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Neuro Kinetics, Inc, i-PAS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID19 epidemic, and institutional guidelines for halt of recruitment during epidemic

Expanded Access Info

Start Date

Feb 22, 2018Actual

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

May 9, 2017

First Submission Date that Met QC Criteria

May 22, 2017

First Posted Date

May 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2021

Last Update Posted Date

May 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paul Rapp, Director, Traumatic Injury Research Program, Uniformed Services University of the Health SciencesPrincipal Investigator

Lead Sponsor

Uniformed Services University of the Health SciencesFED

Collaborators

Name	Class
U.S. Army Medical Research and Development Command	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Neuro Kinetics, Inc, i-PAS	Device	This is a test of i-PAS device reliability only.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Healthy control population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniformed Services University of the Health Sciences		Bethesda	Maryland	20814	United States
The Citadel - Military College of South Carolina

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Upload to FITBIR Database NIH

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided