Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-28 @ 11:42 AM
Study NCT ID:
NCT03165968
Status:
SUSPENDED
Last Update Posted:
2021-05-11
First Post:
2017-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID19 epidemic, and institutional guidelines for halt of recruitment during epidemic', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'The NKI i-PAS device should provide similar signals each time a healthy control participant is tested.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy control population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nA 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.\n\nExclusion Criteria:\n\n* A TBI positive event as determined by the DVBIC (Defense and Veterans Brain Injury Center) Three Question Screening Tool.\n\nAny history of seizures or CNS tumors\n\nA normalized Global Severity Scale of more than 65 on the Symptom Checklist-90-Revised. Any subscale score indicating significant pathology\n\nScores greater than one standard deviation from the mean on all eight sections of the Short Form 36 (SF-36)'}, 'identificationModule': {'nctId': 'NCT03165968', 'acronym': 'NINADiPAS', 'briefTitle': 'Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS', 'organization': {'class': 'FED', 'fullName': 'Uniformed Services University of the Health Sciences'}, 'officialTitle': 'Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD): NeuroKinetics, Inc, iPAS', 'orgStudyIdInfo': {'id': 'MEM 91-2714'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neuro Kinetics, Inc, i-PAS', 'type': 'DEVICE', 'description': 'This is a test of i-PAS device reliability only.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Uniformed Services University of the Health Sciences', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '29409', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Citadel - Military College of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Upload to FITBIR Database NIH'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uniformed Services University of the Health Sciences', 'class': 'FED'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Traumatic Injury Research Program', 'investigatorFullName': 'Paul Rapp', 'investigatorAffiliation': 'Uniformed Services University of the Health Sciences'}}}}