Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-24 @ 2:01 PM
Study NCT ID:
NCT02561403
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2015-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability based on participant ratings', 'timeFrame': 'Acceptability ratings assessed post-intervention (1-month after baseline)'}, {'measure': 'Participant adherence to game play', 'timeFrame': 'Total adherence over the 4 week intervention phase'}, {'measure': 'Change in cognitive functioning based on neurocognitive test battery', 'timeFrame': 'Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)'}], 'secondaryOutcomes': [{'measure': 'Change in self-reported everyday cognitive functioning [Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function inventory]', 'timeFrame': 'Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)'}, {'measure': 'Change in everyday functioning [University of California San Diego (UCSD) Performance Based Skills Assessment (UPSA)]', 'timeFrame': 'Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)'}, {'measure': 'Change in mood symptoms (Geriatric Depression Scale)', 'timeFrame': 'Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)'}, {'measure': 'Change in EVO performance (EVO Monitor)', 'timeFrame': 'Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)'}]}, 'conditionsModule': {'keywords': ['traumatic brain injury (TBI)', 'aging', 'cognitive training', 'Cognitive Aging'], 'conditions': ['TBI (Traumatic Brain Injury)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a pilot trial investigating cognitive training in older Veterans with a history of traumatic brain injury (TBI) to assess training effects, acceptability of training to participants, and to explore whether other factors influence training effects.', 'detailedDescription': 'A study of older Veterans (60-85 years old) who have 1) a history of repetitive mild TBI or at least one moderate TBI and 2) subjective cognitive complaints. Participants will be randomized to one of three conditions for 4 weeks: Project:Evolution (EVO) multitask video game, EVO words video game, or an assessment only control condition. Participants will complete assessment visits at baseline, post-intervention (1 month after baseline), and 3 months post-intervention (4 months after baseline).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 60-85\n2. Have experienced more than one mild TBI or at least one moderate TBI over their lifetime\n3. Have current cognitive problems based on self-report\n4. Vision adequate to see test stimuli\n5. Hearing adequate to understand the examiner\n6. Fluent in English in order to understand task instructions\n7. Demonstrate capacity to consent to participate in research\n8. Mini-Mental Status Exam (MMSE) score ≥ 25\n\nExclusion Criteria:\n\n1. History of penetrating brain injury\n2. Active disabling neurological condition (e.g., stroke, brain tumor, multiple sclerosis)\n3. History of severe psychiatric illness (i.e., schizophrenia, bipolar disorder, schizoaffective disorder)\n4. Active drug use or active heavy alcohol use\n5. History of severe TBI\n6. History of a dementia diagnosis\n7. Individuals who are physically unable to use an iPad for 30 minutes at a time per day will be excluded, such as individuals with debilitating arthritis or tremor'}, 'identificationModule': {'nctId': 'NCT02561403', 'briefTitle': 'Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury', 'organization': {'class': 'FED', 'fullName': 'San Francisco Veterans Affairs Medical Center'}, 'officialTitle': 'Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2', 'orgStudyIdInfo': {'id': '14-14955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVO multitask video game', 'interventionNames': ['Behavioral: EVO multitask video game']}, {'type': 'EXPERIMENTAL', 'label': 'EVO words video game', 'interventionNames': ['Behavioral: EVO words video game']}, {'type': 'NO_INTERVENTION', 'label': 'Assessment Only'}], 'interventions': [{'name': 'EVO multitask video game', 'type': 'BEHAVIORAL', 'description': 'Participants will play a multitasking game for 4 weeks', 'armGroupLabels': ['EVO multitask video game']}, {'name': 'EVO words video game', 'type': 'BEHAVIORAL', 'description': 'Participants will play a word puzzle game for 4 weeks', 'armGroupLabels': ['EVO words video game']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94599', 'city': 'Yountville', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Home of California', 'geoPoint': {'lat': 38.40158, 'lon': -122.36081}}], 'overallOfficials': [{'name': 'Allison Kaup, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Francisco Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'VA Office of Research and Development', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Psychologist', 'investigatorFullName': 'Allison Kaup', 'investigatorAffiliation': 'San Francisco Veterans Affairs Medical Center'}}}}