Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-04 @ 6:00 AM
Study NCT ID:
NCT02602418
Status:
UNKNOWN
Last Update Posted:
2019-10-02
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Correlates of Working Memory Training for HIV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Improvement Index on Cogmed™', 'timeFrame': '1 month after training, and 6 month after training completion', 'description': 'This is generated by the computer training program based on the trained tasks.'}, {'measure': 'Changes in Performances on near transfer working memory tasks', 'timeFrame': '1 month after training, and 6 month after training completion', 'description': 'Verbal working memory and spatial working memory tasks'}, {'measure': 'Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures', 'timeFrame': '1 month after training, and 6 month after training completion', 'description': 'Brain activation during the performance of working memory and attention tasks'}], 'secondaryOutcomes': [{'measure': 'Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)', 'timeFrame': 'Baseline, 1 month after training, and 6 month after training completion', 'description': 'Performance and improvements on cognitive tests may vary at baseline and after training based on LMX1A genotypes'}, {'measure': 'Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)', 'timeFrame': '1 month after training, and 6 month after training completion', 'description': "Improvement on BRIEF-A, a self-reported evaluation of the person's executive function during their activities of daily living."}, {'measure': 'Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes', 'timeFrame': '1 month after training, and 6 month after training completion', 'description': 'Brain activation during working memory performance may vary at baseline, 1-month or 6-months based on the different LMX1A genotypes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Immunodeficiency Virus (HIV)', 'working memory training', 'brain function', 'functional magnetic resonance imaging (fMRI)'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '41380114', 'type': 'DERIVED', 'citation': 'Chang L, Liang H, Ernst T, Cunningham E, Wang J, Baptiste J, Lohaugen GCC. LMX1A and APOE varepsilon Genotype Associations With Working Memory Training Effects in HIV and Non-HIV: A Randomized Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2026 Jan;13(1):e200519. doi: 10.1212/NXI.0000000000200519. Epub 2025 Dec 11.'}, {'pmid': '26833223', 'type': 'DERIVED', 'citation': 'Chang L, Lohaugen GC, Douet V, Miller EN, Skranes J, Ernst T. Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:62. doi: 10.1186/s13063-016-1160-4.'}]}, 'descriptionModule': {'briefSummary': 'Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. To address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in HIV-infected and infected individuals.', 'detailedDescription': 'The Overall Goals are to perform a double blind placebo-controlled study using Cogmed™ to determine whether this adaptive WM training program will benefit HIV-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (WM) training. Lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (CSF) monoamine levels might be related to WM function before and after the training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for HIV-infected participants :\n\n1. Men or women of any ethnicity, ages\\>18 years and able to provide informed consent,\n2. HIV seropositive (with documentation from medical records),\n3. Stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study.\n\nInclusion Criteria for Seronegative (SN) healthy participants :\n\n1. Men or women of any ethnicity, ages \\> 18 years and able to give informed consent,\n2. Seronegative for HIV\n\nExclusion criteria :\n\n1. Confounding co-morbid psychiatric illness\n2. Confounding neurological disorders\n3. Abnormal screening laboratory tests (\\>2 SD) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders)\n4. Medications that might influence outcome measures\n5. Current or history of drug dependence within the past two years\n6. Positive urine toxicology screen\n7. Inability to read at an 8th grade level\n8. Other contraindications for MR studies'}, 'identificationModule': {'nctId': 'NCT02602418', 'briefTitle': 'Neural Correlates of Working Memory Training for HIV Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial', 'orgStudyIdInfo': {'id': '4R01DA035659-04', 'link': 'https://reporter.nih.gov/quickSearch/4R01DA035659-04', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '4R01DA035659-04', 'link': 'https://reporter.nih.gov/quickSearch/4R01DA035659-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV Positive participants', 'description': 'Intervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.', 'interventionNames': ['Other: Adaptive WM CogMed Training', 'Other: Nonadaptive WM CogMed Training']}, {'type': 'OTHER', 'label': 'Seronegative particpiants', 'description': 'Intervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.', 'interventionNames': ['Other: Adaptive WM CogMed Training', 'Other: Nonadaptive WM CogMed Training']}], 'interventions': [{'name': 'Adaptive WM CogMed Training', 'type': 'OTHER', 'description': '12 different computerized visual and spatial Working Memory tasks will be presented at each sessoin. Each session will involve 8 of the 12 tasks, and each subject is required to complete 25 training sessions, 30-40 minutes per day, 4-5 days per week over a 5-8 week period (minimum 20 sessions). The tasks will become more difficult in an "adaptive" manner, which is hypothesized as optimal for learning and training effects.', 'armGroupLabels': ['HIV Positive participants', 'Seronegative particpiants']}, {'name': 'Nonadaptive WM CogMed Training', 'type': 'OTHER', 'description': 'The same 12 computerized visual and spatial working memory tasks will be presented, but at a fixed ("non-adaptive") and low difficulty level. 5 sessions per week x 5 weeks fora total of 25 sessions (minimum 20 sessions).', 'armGroupLabels': ['HIV Positive participants', 'Seronegative particpiants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Linda Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland Baltimiore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Linda Chang, M.D.', 'investigatorAffiliation': 'University of Maryland, College Park'}}}}