Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-06 @ 2:02 AM
Study NCT ID:
NCT02518204
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Correlation coefficients (Pearson's r) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1", 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1', 'timeFrame': '1 day'}, {'measure': "Correlation coefficients (Pearson's r and ICC) of raw scores of BPT subtests compared to raw scores of their NP correlates at Time 1", 'timeFrame': '1 day'}, {'measure': "Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1", 'timeFrame': '1 day'}, {'measure': "Correlation coefficients (Pearson's r and ICC) of raw and scaled scores of BPT subtests at Time 1 and Time 2 as measures of test-retest reliability", 'timeFrame': '2 weeks'}, {'measure': "Correlation coefficients (Pearson's r and ICC) of composite indices of BPT and NP at Time 1 and Time 2 as measures of reliability", 'timeFrame': '2 weeks'}, {'measure': "Correlation coefficients (Pearson's r and ICC) of BPT Grand Index and NP Overall Index at Time 1 and Time 2 as measures of reliability", 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive assessment', 'neuropsychological assessment', 'Brain Performance Test', 'computerized assessment'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the concurrent validity between the Brain Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological assessments (NP).', 'detailedDescription': 'This will be a multi-site, randomized, counterbalanced, two-period, two-sequence, validation study of the online, unsupervised Brain Performance Test (BPT). Over the course of 14 days, participants will complete two in-clinic visits during which they will complete both the BPT and in-person neuropsychological assessments (NP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Native English speaker\n* Capable and willing to provide informed consent\n* Able to use a computer and mouse without assistance\n* Limited (\\< 3 days) or no experience with Lumosity.com\n* Limited (\\< 3 days) or no experience with other cognitive training programs (e.g., FitBrains, CogMed)\n* Willing to refrain from online cognitive training during the course of the study\n* No recent (\\<1 years) experience with either computer-based or in-person neuropsychological tests (e.g., WAIS-IV, WISC, Halstead-Reitan Battery, MATRICS, CogState, CNS Vital Signs)\n* Good general health assessed via self-reported online physical questionnaire and medical history questionnaire\n\nExclusion Criteria:\n\n* Illiterate or unable to understand written English sufficiently to comprehend study instructions and consent form\n* Uncorrected visual impairment (beyond that required to qualify for a California Driver's License) that may impact the ability to complete assessments (self-report or determined by the clinician)\n* Uncorrected auditory impairment that may impact the ability to complete assessments (self-report or determined by the clinician)\n* Self-reported clinical diagnosis for primary psychiatric or neurological disorder (e.g., schizophrenia, multiple sclerosis, attention deficit hyperactivity disorder, Parkinson's disease, epilepsy)\n* Self-reported history of concussion or traumatic brain injury, that is considered clinically significant in the opinion of the investigator (e.g. loss of consciousness ≤ 30 minutes)\n* Self-reported diagnosis of mental retardation or pervasive developmental disorder\n* Self-reported diagnosis of Mild Cognitive Impairment, Alzheimer's disease, or other dementia\n* Self-reported history of sustained substance or alcohol abuse or dependence, that is considered clinically significant in the opinion of the investigator (e.g. as defined by DSM-5)\n* Self-report that subject is currently taking an antipsychotic, antidepressant, anti-anxiety, or a cognitively-enhancing medication (e.g. Ritalin), or in the last 72 hours, narcotics for pain or other medications that may impact cognitive performance (e.g. sleeping medications/aides or cold/allergy medications)\n* Any other significant medical condition that could impact cognitive performance or result in cognitive impairment in the opinion of the investigator\n* Score \\<28 on the MMSE\n* Positive urine test for recent substance use on either testing day\n* Breath Alcohol Content of 0.01% or greater on either testing day"}, 'identificationModule': {'nctId': 'NCT02518204', 'briefTitle': 'Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Labs, Inc.'}, 'officialTitle': 'Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults', 'orgStudyIdInfo': {'id': 'LL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BPT, NP', 'description': 'Computerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments', 'interventionNames': ['Other: BPT', 'Other: NP']}, {'type': 'EXPERIMENTAL', 'label': 'NP, BPT', 'description': 'Conventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery', 'interventionNames': ['Other: BPT', 'Other: NP']}], 'interventions': [{'name': 'BPT', 'type': 'OTHER', 'description': 'Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.', 'armGroupLabels': ['BPT, NP', 'NP, BPT']}, {'name': 'NP', 'type': 'OTHER', 'description': 'Conventional in-person Neuropsychological Assessments (NP)\n\nSubtests from:\n\n* HRB: Halstead-Reitan Battery\n* MATRICS: Measurement and Treatment Research to Improve Cognition in Schizophrenia\n* WAIS-IV: Weschler Adult Intelligence Scale - IV', 'armGroupLabels': ['BPT, NP', 'NP, BPT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research Center', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'South Bay Research Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'David Walling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Collaborative Neuroscience Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumos Labs, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Collaborative Neuroscience Network', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}