Viewing Study NCT05270408

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Ignite Creation Date: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
Study NCT ID: NCT05270408
Status: COMPLETED
Last Update Posted: 2025-03-05
First Post: 2021-12-30
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christian.LoBue@utsouthwestern.edu', 'phone': '2146485265', 'title': 'Dr Christian LoBue', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored from the start of assigned treatments (1 mA, 2 mA, and sham) through study completion. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 2-month visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Patient with pre-existing cardiac condition discovered to have cardiac decline during a medical visit. Hospitalized and treated. Participant recovered well. Not considered related to the treatment protocol.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'RAVLT total learning Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '18.0', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'RAVLT Total Learning Immediate post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '12.8', 'groupId': 'OG002'}]}]}, {'title': 'RAVLT Total Learning 2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'RAVLT Delayed Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '22.3', 'spread': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'RAVLT Delayed Immediate Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '22.3', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'RAVLT Delayed 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.93', 'groupDescription': 'RAVLT Total Learning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.69', 'groupDescription': 'RAVLT Total Learning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.74', 'groupDescription': 'RAVLT Delayed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.64', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.19', 'groupDescription': 'RAVLT Delayed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'BVMT Total Learning Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '21.7', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': 'BVMT Total Learning Immediate Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'BVMT Total Learning 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'BVMT Delayed Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '20.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'BVMT Delayed Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'BVMT Delayed 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03', 'groupDescription': 'BVMT total learning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.86', 'groupDescription': 'BVMT total learning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.04', 'groupDescription': 'BVMT delayed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.23', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.69', 'groupDescription': 'BVMT delayed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The BVMT-R is a visual episodic memory task where 6 simple designs are shown for 10 seconds in a 2 x 3 matrix for 3 learning trials followed by a 25-minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better visual episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Boston Naming Test Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '31.6', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '30.1', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.4', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '31.9', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.5', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '8.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The Boston Naming Test Short Form is a 30 item version of the task (odd and even item versions of the full test) and a measure of language. The subject is shown pictures of objects and is required to correctly name them as quickly as possible. The outcome measure for this task is the total number of correct responses, ranging from 0-30. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '32.7', 'spread': '14.5', 'groupId': 'OG002'}]}]}, {'title': 'Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '40.4', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '35.9', 'spread': '14.2', 'groupId': 'OG002'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '32.1', 'spread': '12.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The DKEFS phonemic verbal fluency task is a measure of language. The subject is required to name as many words as possible that begin with specified letters within 1 minute. Three different letter trials are completed. The outcome measure for this task is the total number of correct responses across the trials, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.\n\nSham Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': 'Participants will receive 1 mA active HD-tDCS for 20 minutes.\n\nActive Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': 'Participants will receive 2 mA active HD-tDCS for 20 minutes.\n\nActive Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.2', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '6.0', 'groupId': 'OG002'}]}]}, {'title': 'Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '5.6', 'groupId': 'OG002'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '30.2', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '23.9', 'spread': '4.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG002'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The DKEFS semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals and people names as possible within 1 minute. The outcome measure for this task is the total number of correct responses for both conditions combined, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Trail Making Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.3', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '20.6', 'spread': '13.2', 'groupId': 'OG002'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '10.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete two conditions, involving number sequencing and then number-letter switching. The outcome measure for this task is the time in seconds to complete the number-letter switching condition, ranging from 15-300. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Several participants were unable to complete the test in the administration time due to the level of cognitive impairment. Thus, the test was discontinued for many participants, prohibiting scores to be derived for several in data analysis. Scores are therefore missing for these, and the number that was able to complete the test varied across conditions and time points.'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Southwestern Assessment of Processing Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.6', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': 'Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '31.0', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '27.9', 'spread': '8.8', 'groupId': 'OG002'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '29.1', 'spread': '10.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.96', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.68', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "Eta2 effect sizes produced from the pairwise comparisons were transformed to Cohen's d for examination of effect sizes. A small/weak effect size was demonstrated (Cohen's d = 0.10), when adjusting for baseline performance."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The Southwestern Assessment of Processing Speed is a measure of psychomotor processing speed. The subject is required to transcribe numbers to their corresponding written symbol as quickly as possible within 60 seconds. The outcome measure for this task is the total number of correct responses, ranging from 0-75. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant lost to follow-up. Data missing for this measure on one participant in active 2 mA group.'}, {'type': 'SECONDARY', 'title': 'Change in Score on the DKEFS Color-Word Interference Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'OG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'OG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.5', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '25.1', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '35.0', 'spread': '14.4', 'groupId': 'OG002'}]}]}, {'title': 'Immediate Posttreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '34.2', 'spread': '13.8', 'groupId': 'OG002'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '14.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measures for this task was the response inhibition trial and the switching trial, which are scored as the time in seconds to complete the conditions, ranging from 20-180. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.', 'unitOfMeasure': 'T-score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Several participants were unable to complete the test in the administration time due to the level of cognitive impairment. Thus, the test was discontinued for many participants, prohibiting scores to be derived for several in data analysis. Scores are therefore missing for these, and the number that was able to complete the test varied across conditions and time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Group', 'description': 'Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.\n\nSham Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.'}, {'id': 'FG001', 'title': 'Active Stimulation at 1mA', 'description': 'Participants will receive 1 mA active HD-tDCS for 20 minutes.\n\nActive Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.'}, {'id': 'FG002', 'title': 'Active Stimulation at 2mA', 'description': 'Participants will receive 2 mA active HD-tDCS for 20 minutes.\n\nActive Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.'}], 'periods': [{'title': 'Assigned to Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Assigned to Treatment With Mild Cognitive Impairment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Assigned to Treatment With Alzheimer Dementia', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Started Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Started Treatment With Diagnosis of Mild Cognitive Impairment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Started Treatment With Diagnosis of Alzheimer Dementia', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Follow-Up at 2 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Analysis - Primary Outcomes Available', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Outcomes Available With Mild Cognitive Impairment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Outcomes Available With Alzheimer Dementia', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Group', 'description': 'sham HD-tDCS for 20 minutes, meaning no stimulation.'}, {'id': 'BG001', 'title': 'Active Stimulation at 1mA', 'description': '1 mA active HD-tDCS for 20 minutes.'}, {'id': 'BG002', 'title': 'Active Stimulation at 2mA', 'description': '2 mA active HD-tDCS for 20 minutes.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69.4', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '74.0', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '70.8', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '14.3', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '14.4', 'spread': '2.4', 'groupId': 'BG002'}, {'value': '14.7', 'spread': '2.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '2.3', 'spread': '2.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing for 3 participants'}], 'populationDescription': 'Participants with mild cognitive impairment were not analyzed given the limited numbers that were recruited, allocated to treatment, and with data on outcome measures.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-28', 'size': 398488, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-10T11:12', 'hasProtocol': True}, {'date': '2024-07-08', 'size': 352665, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-10T11:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2021-12-30', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-27', 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The BVMT-R is a visual episodic memory task where 6 simple designs are shown for 10 seconds in a 2 x 3 matrix for 3 learning trials followed by a 25-minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better visual episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured.'}, {'measure': 'Change in Score on the Boston Naming Test Short Form', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The Boston Naming Test Short Form is a 30 item version of the task (odd and even item versions of the full test) and a measure of language. The subject is shown pictures of objects and is required to correctly name them as quickly as possible. The outcome measure for this task is the total number of correct responses, ranging from 0-30. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.'}, {'measure': 'Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The DKEFS phonemic verbal fluency task is a measure of language. The subject is required to name as many words as possible that begin with specified letters within 1 minute. Three different letter trials are completed. The outcome measure for this task is the total number of correct responses across the trials, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.'}, {'measure': 'Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The DKEFS semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals and people names as possible within 1 minute. The outcome measure for this task is the total number of correct responses for both conditions combined, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.'}, {'measure': 'Change in Score on the Trail Making Test', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete two conditions, involving number sequencing and then number-letter switching. The outcome measure for this task is the time in seconds to complete the number-letter switching condition, ranging from 15-300. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.'}, {'measure': 'Change in Score on the Southwestern Assessment of Processing Speed', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The Southwestern Assessment of Processing Speed is a measure of psychomotor processing speed. The subject is required to transcribe numbers to their corresponding written symbol as quickly as possible within 60 seconds. The outcome measure for this task is the total number of correct responses, ranging from 0-75. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.'}, {'measure': 'Change in Score on the DKEFS Color-Word Interference Test', 'timeFrame': 'Baseline, immediately following last treatment session, and 2-months post treatment', 'description': 'The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measures for this task was the response inhibition trial and the switching trial, which are scored as the time in seconds to complete the conditions, ranging from 20-180. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial direct current stimulation', 'Alzheimer Disease', 'Mild Cognitive Impairment', 'Dementia', 'MCI', 'Mild neurocognitive disorder', 'Amnestic', 'Pre- alzheimer'], 'conditions': ['Alzheimer Disease', 'Mild Cognitive Impairment', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '39863318', 'type': 'DERIVED', 'citation': "LoBue C, Chiang HS, Salter A, McClintock S, Nguyen TP, Logan R, Smernoff E, Pandya S, Hart J. High definition transcranial direct current stimulation as an intervention for cognitive deficits in Alzheimer's dementia: A randomized controlled trial. J Prev Alzheimers Dis. 2025 Feb;12(2):100023. doi: 10.1016/j.tjpad.2024.100023. Epub 2025 Jan 1."}]}, 'descriptionModule': {'briefSummary': 'The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.', 'detailedDescription': 'This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 50 and older\n2. Fluent in English\n3. Active diagnosis of MCI or dementia\n\nExclusion Criteria:\n\n1. Substance use disorder\n2. Has metal fragments in head\n3. Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)'}, 'identificationModule': {'nctId': 'NCT05270408', 'briefTitle': 'Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia', 'orgStudyIdInfo': {'id': 'STU-2021-0974'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active stimulation at 1mA', 'description': 'Participants will receive 1 mA active HD-tDCS for 20 minutes.', 'interventionNames': ['Device: Active Transcranial direct current stimulation (STARStim 8)']}, {'type': 'EXPERIMENTAL', 'label': 'Active stimulation at 2mA', 'description': 'Participants will receive 2 mA active HD-tDCS for 20 minutes.', 'interventionNames': ['Device: Active Transcranial direct current stimulation (STARStim 8)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.', 'interventionNames': ['Device: Sham Transcranial direct current stimulation (STARStim 8)']}], 'interventions': [{'name': 'Active Transcranial direct current stimulation (STARStim 8)', 'type': 'DEVICE', 'description': 'Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.', 'armGroupLabels': ['Active stimulation at 1mA']}, {'name': 'Active Transcranial direct current stimulation (STARStim 8)', 'type': 'DEVICE', 'description': 'Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.', 'armGroupLabels': ['Active stimulation at 2mA']}, {'name': 'Sham Transcranial direct current stimulation (STARStim 8)', 'type': 'DEVICE', 'description': 'Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Christian LoBue, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'Christian Lobue', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}