Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT03180905
Status:
UNKNOWN
Last Update Posted:
2023-09-29
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ImPACT Normative Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity', 'timeFrame': '12 Months', 'description': 'ImPACT Online compared to Brief Visuospatial Memory Test'}, {'measure': 'Validity', 'timeFrame': '12 Months', 'description': 'ImPACT Online compared to Symbol Digit Modalities Test'}, {'measure': 'Validity', 'timeFrame': '12 Months', 'description': 'ImPACT Online compared to Color Trails'}, {'measure': 'Validity', 'timeFrame': '12 Months', 'description': 'ImPACT Online compared to Hopkins Verbal Learning Test.'}], 'secondaryOutcomes': [{'measure': 'Reliability', 'timeFrame': 'Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.', 'description': 'Reliability will be established through a test/re-test. Online ImPACT will be administered at 2 time points to establish results should be stable over time.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Brain Concussion']}, 'descriptionModule': {'briefSummary': 'The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 60-80\n2. Primary English speaking or fluent in English.\n3. Currently does not reside in a skilled nursing facility.\n4. Currently not suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.\n5. No known physical, neurological, behavioral or psychological impairment that would affect their ability to perform the test.\n6. Hearing or vision impairments that have not been corrected within normal limits.\n7. A score of 24 or greater on the MMSE (Mini-Mental State Examination).\n\nExclusion Criteria:\n\n1. English is not their primary language nor are they proficient in the English language.\n2. Currently resides in a skilled nursing facility.\n3. Currently suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.\n4. Known physical, neurological, behavioral, or psychological impairment that would affect their ability to take or complete the test.\n5. Hearing or vision impairments that would affect their ability to perform the test.\n6. Score of 23 or below on the MMSE(Mini-Mental State Examination).'}, 'identificationModule': {'nctId': 'NCT03180905', 'briefTitle': 'ImPACT Normative Extension', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImPACT Applications, Inc.'}, 'officialTitle': 'ImPACT Normative Extension', 'orgStudyIdInfo': {'id': 'QPR-17-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Validity', 'description': 'ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.', 'interventionNames': ['Device: ImPACT Online/Paper Pencil Tests']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test/Re-Test', 'description': 'ImPACT Online will be administered at 2 time points', 'interventionNames': ['Device: ImPACT Online']}], 'interventions': [{'name': 'ImPACT Online/Paper Pencil Tests', 'type': 'DEVICE', 'description': 'Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests', 'armGroupLabels': ['Validity']}, {'name': 'ImPACT Online', 'type': 'DEVICE', 'description': 'ImPACT Online will be administered at 2 time points.', 'armGroupLabels': ['Test/Re-Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34236', 'city': 'Sarasota', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Comprehensive Med Psych Systems, Inc.', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '12222', 'city': 'Albany', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Albany', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '15228', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jane Luce', 'role': 'CONTACT', 'email': 'jluce@impacttest.com', 'phone': '412-567-8400', 'phoneExt': '938'}], 'facility': 'ImPACT Applications Inc.', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Jane Luce', 'role': 'CONTACT', 'email': 'jluce@impacttest.com', 'phone': '412-567-8400', 'phoneExt': '938'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImPACT Applications, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}