Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-01 @ 2:35 AM
Study NCT ID:
NCT02597504
Status:
TERMINATED
Last Update Posted:
2023-09-29
First Post:
2015-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Neurocognitive Screening Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058388', 'term': 'penclomedine'}, {'id': 'D011517', 'term': 'Prothrombin Time'}], 'ancestors': [{'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1600}}, 'statusModule': {'whyStopped': 'Loss of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability will be established through a test-retest to establish results should be stable over time', 'timeFrame': '12 Months'}, {'measure': 'Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Concussion', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.\n\nThe purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 12-75 (Adult version), 6-11 (pediatric version)\n* Primary English speaking or fluent in English.\n* No known special education diagnosis excluding a 504 designation.\n* Currently not suffering from a concussion or being treated for a concussion.\\*\n* No known physical or psychological impairment that would affect their ability to perform the test.\n\nExclusion Criteria:\n\n* Documentation of a known special education diagnosis other than a 504 designation.\n* English is not their primary language nor are they proficient in the English language.\n* Currently suffering from a concussion or being treated for a concussion.\\*\n* Any known physical or psychological impairment that would affect their ability to perform the test.\n\n * Note: Unless specifically required by the particular study (i.e., a discriminant validity study differentiating concussed versus non-concussed individuals).'}, 'identificationModule': {'nctId': 'NCT02597504', 'briefTitle': 'Development of a Neurocognitive Screening Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImPACT Applications, Inc.'}, 'officialTitle': 'Development of a Neurocognitive Screening Test', 'orgStudyIdInfo': {'id': 'QPR-15-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standardization', 'description': 'individuals assigned to this group will be healthy volunteers and will take the Quick Test.', 'interventionNames': ['Device: Quick Test']}, {'type': 'EXPERIMENTAL', 'label': 'Validity and Reliability', 'description': 'Reliability:\n\nTest-Retest\n\nValidity:\n\nConcurrent:Quick Test administered with ImPACT online Discriminant: Concussed patient administered Quick Test Construct: Determine agreement between Quick Test and and paper and pencil test.', 'interventionNames': ['Other: Pen and paper neuropsychological test', 'Device: Quick Test']}], 'interventions': [{'name': 'Pen and paper neuropsychological test', 'type': 'OTHER', 'description': 'Will be administered for Construct Validity to determine agreement with Quick Test', 'armGroupLabels': ['Validity and Reliability']}, {'name': 'Quick Test', 'type': 'DEVICE', 'description': 'Quick Test, computerized test will be administered to all subjects.', 'armGroupLabels': ['Standardization', 'Validity and Reliability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'FastMed Urgent Care', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72701', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '21114', 'city': 'Crofton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Head First', 'geoPoint': {'lat': 39.00178, 'lon': -76.68747}}, {'zip': '15288', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jim Gyurke', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImPACT Applications, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}