Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05551520
Status:
UNKNOWN
Last Update Posted:
2023-07-05
First Post:
2022-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ImPACT Version 4-Touchscreen: Normative and Reliability Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015203', 'term': 'Reproducibility of Results'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1437}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity', 'timeFrame': '12 months', 'description': 'ImPACT Touchscreen performs within normal parameters of ImPACT Online'}], 'secondaryOutcomes': [{'measure': 'Reliability', 'timeFrame': 'Baseline test will be administered at enrollment and re-test will be administered within 60 days of baseline test.', 'description': 'Reliability will be established through a test/re-test. ImPACT Touchscreen 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': {'keywords': ['Brain'], 'conditions': ['Concussion']}, 'descriptionModule': {'briefSummary': 'This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.', 'detailedDescription': 'This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 12-80\n2. Primary English speaking or fluent in English\n\nExclusion Criteria:\n\n1. Documentation of a known special education diagnosis other than a 504 designation.\n2. History of concussion less than 6 months to the study participation\n3. Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.'}, 'identificationModule': {'nctId': 'NCT05551520', 'briefTitle': 'ImPACT Version 4-Touchscreen: Normative and Reliability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImPACT Applications, Inc.'}, 'officialTitle': 'ImPACT Version 4-Touchscreen: Normative and Reliability Study', 'orgStudyIdInfo': {'id': 'QPR-21-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Normative', 'description': "ImPACT will be administered to participant's for a baseline test.", 'interventionNames': ['Device: Normative']}, {'type': 'OTHER', 'label': 'Reliability', 'description': "ImPACT will be administered to participant's within 60 days of baseline test.", 'interventionNames': ['Device: Reliability']}], 'interventions': [{'name': 'Normative', 'type': 'DEVICE', 'description': 'ImPACT will be administered at baseline testing', 'armGroupLabels': ['Normative']}, {'name': 'Reliability', 'type': 'DEVICE', 'description': 'ImPACT will be administered again within 60 days of baseline test', 'armGroupLabels': ['Reliability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52241', 'city': 'Coralville', 'state': 'Iowa', 'country': 'United States', 'facility': 'ImPACT Applications, Inc.', 'geoPoint': {'lat': 41.6764, 'lon': -91.58045}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImPACT Applications, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}