Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT04647032
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2020-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Sponsor:
Organization:
Raw JSON
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'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Divided Attention', 'classes': [{'categories': [{'measurements': [{'value': '8.01', 'spread': '1.56', 'groupId': 'BG000'}, {'value': '8.51', 'spread': '1.65', 'groupId': 'BG001'}, {'value': '8.27', 'spread': '1.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task.', 'unitOfMeasure': 'difficulty level achieved', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Difficulty level is a continuous unitless quantity that relates to the difficulty of the task. Higher is better.'}, {'title': 'Sustained Attention', 'classes': [{'categories': [{'measurements': [{'value': '527', 'spread': '108', 'groupId': 'BG000'}, {'value': '432', 'spread': '56', 'groupId': 'BG001'}, {'value': '481', 'spread': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sustained attention was assessed via response times during the continuous performance task.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Response times to visual targets. Lower is better.'}, {'title': 'Working Memory', 'classes': [{'categories': [{'measurements': [{'value': '6.13', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '6.56', 'spread': '0.81', 'groupId': 'BG001'}, {'value': '6.34', 'spread': '0.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Working memory was assessed as the average maximum number correct from the ACE-X span tasks.', 'unitOfMeasure': 'number correct', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of items remembered. Higher is better.'}, {'title': 'Instrumental Activities of Daily Living', 'classes': [{'categories': [{'measurements': [{'value': '3.92', 'spread': '0.29', 'groupId': 'BG000'}, {'value': '4', 'spread': '0', 'groupId': 'BG001'}, {'value': '3.96', 'spread': '0.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Higher is better (max = 4)'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-02', 'size': 78831, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-19T09:33', 'hasProtocol': True}, {'date': '2021-11-02', 'size': 249998, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-27T11:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2020-11-10', 'resultsFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-19', 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Divided Attention Performance', 'timeFrame': 'Post-tACS (1-day follow-up), approximately 1 week after baseline', 'description': 'Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.'}, {'measure': 'Divided Attention Performance', 'timeFrame': 'Post-tACS (1-month follow-up), approximately 1 month after baseline', 'description': 'Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.'}, {'measure': 'Sustained Attention Performance', 'timeFrame': 'Post-tACS (1-day follow-up), approximately 1 week after baseline', 'description': 'Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.'}, {'measure': 'Sustained Attention Performance', 'timeFrame': 'Post-tACS (1-month follow-up), approximately 1 month after baseline', 'description': 'Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.'}, {'measure': 'Working Memory Performance', 'timeFrame': 'Post-tACS (1-day follow-up), approximately 1 week after baseline', 'description': 'Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.'}, {'measure': 'Working Memory Performance', 'timeFrame': 'Post-tACS (1-month follow-up), approximately 1 month after baseline', 'description': 'Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares'}], 'secondaryOutcomes': [{'measure': 'Instrumental Activities of Daily Living (IADL)', 'timeFrame': 'Post-tACS (1-day follow-up), approximately 1 week after baseline', 'description': 'Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).'}, {'measure': 'Instrumental Activities of Daily Living (IADL)', 'timeFrame': 'Post-tACS (1-month follow-up), approximately 1 month after baseline', 'description': 'Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).', 'detailedDescription': "30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* Grade 12 or more education\n* Normal or corrected to normal vision and hearing\n* Ability to complete cognitive tasks\n* Ability to cooperate and comply with all study procedures\n* Ability to tolerate tACS\n* Montreal Cognitive Assessment score: 17-28\n* -1 z-score on immediate memory, delayed memory, fluency, processing speed, or task switch\n* Self-reported memory complaint\n\nExclusion Criteria:\n\n* Neurological or psychiatric disorders other than mild cognitive impairment\n* Receiving investigational medications or have participated in a trial with investigational medications within last 30 days\n* Family history of epilepsy\n* Implanted electronic devices (e.g., pacemaker)\n* Prior head trauma\n* Pregnant\n* IQ \\< 80\n* Taking cholinesterase inhibitory, memantine, or psychotropic medication\n* Taking anti-depressants or anti-anxiety medication\n* Color blind\n* Substance abuse\n* Glaucoma\n* Macular degeneration\n* Amblyopia (lazy eye)\n* Strabismus (crossed eyes)'}, 'identificationModule': {'nctId': 'NCT04647032', 'briefTitle': 'Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation', 'orgStudyIdInfo': {'id': '132026a'}, 'secondaryIdInfos': [{'id': 'R21AG062395', 'link': 'https://reporter.nih.gov/quickSearch/R21AG062395', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theta Stimulation Group', 'description': 'This group will receive 6 Hz (theta) stimulation', 'interventionNames': ['Device: Transcranial alternating current stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delta Stimulation Group', 'description': 'This group will receive 1 Hz (delta) stimulation', 'interventionNames': ['Device: Transcranial alternating current stimulation']}], 'interventions': [{'name': 'Transcranial alternating current stimulation', 'type': 'DEVICE', 'description': 'Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4', 'armGroupLabels': ['Delta Stimulation Group', 'Theta Stimulation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Theodore Zanto, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be available after the results have been determined and the study researchers are unblinded. The data will be available indefinitely upon request.', 'ipdSharing': 'YES', 'description': 'The dataset includes self-reported information, behavioral and electrophysiological data. The final dataset will be stripped of identifiers prior to release for sharing, thereby anonymizing the data. We will make the anonymized data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This will be in accordance with human subject regulations.', 'accessCriteria': 'Contact PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}