Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-09 @ 6:17 AM
Study NCT ID:
NCT05524233
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Direct Current Stimulation (tDCS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bijan.najafi@bcm.edu', 'phone': '7137987536', 'title': 'Bijan Najafi', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Five participants (out of 10 baseline participants) were withdrawn for the following reasons: loss to follow-up (n=2), headache (n=1), skin irritation (n=1), and withdrawal of consent due to concerns about potential side effects (n=1). Consequently, only five participants completed the 4-week therapy and were included in the final analysis.'}}, 'adverseEventsModule': {'timeFrame': 'up to 4 weeks post initiation of intervention', 'description': 'The definition used will be the same as the clinicaltrials.gov definition.', 'eventGroups': [{'id': 'EG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headches', 'notes': 'One participant experienced headaches during and after the initiation of electrical stimulation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'One participant experienced skin pain during electrical stimulation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 4 weeks', 'description': 'The perceived ease of use of tDCS will be assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire.\n\nParticipants will rate the device on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) across seven questions. The total score will range from 7 (extremely difficult) to 35 (extremely easy), with higher scores indicating greater ease of use. Questions will assess: (1) ease of use, (2) sponge preparation, (3) attaching sponges, (4) starting/stopping therapy, (5) charging, (6) mobility while wearing the device, and (7) task completion during use.\n\nThe TAM subscore will be calculated by summing individual scores, with median values reported as an overall measure of ease of use.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population includes the participants that completed the study.'}, {'type': 'PRIMARY', 'title': 'Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'spread': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 4 weeks', 'description': 'The perceived usefulness of tDCS was assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire.\n\nParticipants rated the usefulness of the device on a 5-point scale: 1 = Decreased Significantly, 2 = Decreased, 3 = Neutral, 4 = Increased, 5 = Increased Significantly. Six questions were used to assess overall perceived usefulness, focusing on benefits related to mental activity, energy levels, memory, attention, concentration, and alertness. The total score ranged from 6 (not at all useful) to 30 (highly useful), with higher values indicating greater perceived usefulness.\n\nThe TAM subscore for perceived usefulness was calculated by summing the individual component scores and determining the median value across participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population includes the participants that completed the study.'}, {'type': 'PRIMARY', 'title': 'Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 4 weeks', 'description': 'The attitude toward use of the tDCS device was assessed using a subscale of the Technology Acceptance Model (TAM) questionnaire.\n\nParticipants will rate their attitude toward use on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) based on two questions: (1) I would continue this therapy after completing the study, and (2) I would recommend this therapy to friends/family. The total score ranges from 2 (extremely difficult) to 10 (extremely easy), with higher scores reflecting a more positive attitude toward the device.\n\nThe TAM subscore is calculated by summing individual component scores, with median values reported, providing an overall measure of perceived ease of use and intention to use.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population includes the participants that completed the study.'}, {'type': 'SECONDARY', 'title': 'Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '11.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 4 weeks', 'description': 'A digit memory test assesses short-term and working memory by having participants recall sequences of numbers presented in either the same order (forward) or reverse order (backward). Scores are based on the longest sequence accurately recalled, with higher scores indicating better memory capacity. This test is commonly used in cognitive evaluations and research to monitor memory function and detect impairments. Percentage of changes in the total score were assessed at the 4-week mark compared to baseline. The range will be -100% to +100%. A score of zero indicates no change in memory performance, positive values reflect improvement, and negative values indicate a decline in memory performance.\n\nThe average scores for all analyzed participants were reported.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '27.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 4 weeks', 'description': 'The Hopkins Verbal Learning Test-Revised (HVLT-R) is a brief neuropsychological tool assessing verbal learning and memory. Participants recall 12 words across three trials (max score: 36) and a delayed recall trial (max score: 12), yielding a total score of 48, with higher scores indicating better memory.\n\nPercentage changes in cumulative scores from baseline to week 4 were evaluated, with averages reported across all participants who completed the study. Scores range from -100% to +100%, where positive values indicate improvement, zero denotes no change, and negative values reflect a decline.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Trail Making Task (TMT) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'title': 'Part A', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Part B', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '15.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 4 weeks', 'description': 'The Trail Making Task (TMT) is a neuropsychological test used to assess attention, processing speed, and task-switching. It consists of two parts: Part A (connecting numbered circles sequentially) and Part B (alternating between numbers and letters). Performance is measured in seconds (completion time) and errors, with shorter times and fewer mistakes indicating better cognitive function. This study reported changes in TMT completion times at week 4 compared to baseline for both parts. Negative values indicate improvement (reduction in completion time compared to baseline) in cognitive function.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in MoCA Score at 4 Weeks Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 4 weeks', 'description': 'Cognitive status was assessed using the Montreal Cognitive Assessment (MoCA), which provides a score ranging from 0 to 30. Changes in scores from baseline to week 4 were reported, with positive values indicating improvement and negative values reflecting deterioration.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.\n\nActive Transcranial Direct Stimulation: Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'MOCA Score', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '3.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Montreal Cognitive Assessment (MoCA) is a screening tool for mild cognitive impairment, assessing memory, attention, language, visuospatial skills, and executive functions. Scores range from 0 to 30, with 26 or above considered normal. Lower scores may indicate cognitive impairment: mild (19-25), moderate (10-18), and severe (below 10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-18', 'size': 491623, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-20T13:16', 'hasProtocol': True}, {'date': '2022-10-27', 'size': 73934, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-11T15:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will be part of the intervention group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-08-30', 'resultsFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-04', 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in MoCA Score at 4 Weeks Compared to Baseline', 'timeFrame': 'Baseline - 4 weeks', 'description': 'Cognitive status was assessed using the Montreal Cognitive Assessment (MoCA), which provides a score ranging from 0 to 30. Changes in scores from baseline to week 4 were reported, with positive values indicating improvement and negative values reflecting deterioration.'}], 'primaryOutcomes': [{'measure': 'Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)', 'timeFrame': 'At 4 weeks', 'description': 'The perceived ease of use of tDCS will be assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire.\n\nParticipants will rate the device on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) across seven questions. The total score will range from 7 (extremely difficult) to 35 (extremely easy), with higher scores indicating greater ease of use. Questions will assess: (1) ease of use, (2) sponge preparation, (3) attaching sponges, (4) starting/stopping therapy, (5) charging, (6) mobility while wearing the device, and (7) task completion during use.\n\nThe TAM subscore will be calculated by summing individual scores, with median values reported as an overall measure of ease of use.'}, {'measure': 'Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)', 'timeFrame': 'At 4 weeks', 'description': 'The perceived usefulness of tDCS was assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire.\n\nParticipants rated the usefulness of the device on a 5-point scale: 1 = Decreased Significantly, 2 = Decreased, 3 = Neutral, 4 = Increased, 5 = Increased Significantly. Six questions were used to assess overall perceived usefulness, focusing on benefits related to mental activity, energy levels, memory, attention, concentration, and alertness. The total score ranged from 6 (not at all useful) to 30 (highly useful), with higher values indicating greater perceived usefulness.\n\nThe TAM subscore for perceived usefulness was calculated by summing the individual component scores and determining the median value across participants.'}, {'measure': 'Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)', 'timeFrame': 'At 4 weeks', 'description': 'The attitude toward use of the tDCS device was assessed using a subscale of the Technology Acceptance Model (TAM) questionnaire.\n\nParticipants will rate their attitude toward use on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) based on two questions: (1) I would continue this therapy after completing the study, and (2) I would recommend this therapy to friends/family. The total score ranges from 2 (extremely difficult) to 10 (extremely easy), with higher scores reflecting a more positive attitude toward the device.\n\nThe TAM subscore is calculated by summing individual component scores, with median values reported, providing an overall measure of perceived ease of use and intention to use.'}], 'secondaryOutcomes': [{'measure': 'Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline', 'timeFrame': 'Baseline - 4 weeks', 'description': 'A digit memory test assesses short-term and working memory by having participants recall sequences of numbers presented in either the same order (forward) or reverse order (backward). Scores are based on the longest sequence accurately recalled, with higher scores indicating better memory capacity. This test is commonly used in cognitive evaluations and research to monitor memory function and detect impairments. Percentage of changes in the total score were assessed at the 4-week mark compared to baseline. The range will be -100% to +100%. A score of zero indicates no change in memory performance, positive values reflect improvement, and negative values indicate a decline in memory performance.\n\nThe average scores for all analyzed participants were reported.'}, {'measure': 'Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline', 'timeFrame': 'Baseline - 4 weeks', 'description': 'The Hopkins Verbal Learning Test-Revised (HVLT-R) is a brief neuropsychological tool assessing verbal learning and memory. Participants recall 12 words across three trials (max score: 36) and a delayed recall trial (max score: 12), yielding a total score of 48, with higher scores indicating better memory.\n\nPercentage changes in cumulative scores from baseline to week 4 were evaluated, with averages reported across all participants who completed the study. Scores range from -100% to +100%, where positive values indicate improvement, zero denotes no change, and negative values reflect a decline.'}, {'measure': 'Changes in Trail Making Task (TMT) From Baseline', 'timeFrame': 'Baseline - 4 weeks', 'description': 'The Trail Making Task (TMT) is a neuropsychological test used to assess attention, processing speed, and task-switching. It consists of two parts: Part A (connecting numbered circles sequentially) and Part B (alternating between numbers and letters). Performance is measured in seconds (completion time) and errors, with shorter times and fewer mistakes indicating better cognitive function. This study reported changes in TMT completion times at week 4 compared to baseline for both parts. Negative values indicate improvement (reduction in completion time compared to baseline) in cognitive function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive impairment', 'Brain fog', 'Transcranial stimulation'], 'conditions': ['Brain Fog']}, 'descriptionModule': {'briefSummary': "Cognitive impairment refers to when an individual struggles to learn, concentrate, remember, or make decisions. This can be due to underlying neurological diseases (i.e. Alzheimer's disease, dementia, etc.), caused by viral illness (i.e. brain fog experienced by COVID-19 survivors) or physical trauma (i.e. concussion). Recent reports indicate that two out of three Americans experience some amount of cognitive impairment in their lifetime.\n\nThere are a number of therapies that have been used to help address this condition. One of these is transcranial direct current stimulation (tDCS), which delivers sustained direct current to to the head area via electrodes. A number of studies have indicated that this form of therapy is safe and efficacious at inducing neuroplasticity and exciting neuronal activity. These factors can help improve aspects of cognitive functioning such as working memory, learning, and task performance.\n\nThe purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless, transcranial direct current stimulation for people with cognitive impairments.", 'detailedDescription': 'Sample size (n=10) is convenient and designed to explore acceptability and feasibility. Participants who are enrolled will be provided a tDCS device to use for a period of four weeks. They will have two study visits, baseline (BL) and the 4th week visit (W4). During each visit participants will answer various questionnaires to assess patient-reported outcomes such as sleep quality, cognitive impairment, depression, anxiety, fatigue, and user acceptability.\n\nThe entire cohort will receive a transcranial direct stimulation (tDCS) device which uses LIFTiD Neurostimulation technology (RPW TECHNOLOGY, LLC, New York, USA). Participants will take the device home and daily, they will use the device for a maximum of 20 minutes to stimulate neuroplasticity. During the stimulation period they will be asked to perform a light activity such as reading, checking emails, etc. The participants will return to the McNair Campus for their final visit after 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (aged 18+) suffering from poor working memory, brain fog, or cognitive impairments (such as dementia, Alzheimer's, concussions, etc); ability to attend to the clinic for visits\n\nExclusion Criteria:\n\n* Severe cognitive decline that reduces their ability to interact with the tDCS device; Major visual or hearing weakness reduces the ability to interact with tDCS device; Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), previous major amputations, and claudication; Demand-type cardiac pacemaker, implanted defibrillator, implanted metal plate in the brain or head, or other implanted electronic devices; Epilepsy, seizures, brain lesions, or severe heart disease; Sensitive skin or rash, broken skin, or open wounds; Pregnancy; and any conditions that may interfere with outcomes or increase the risk of the use tDCS based on the judgement of clinicians"}, 'identificationModule': {'nctId': 'NCT05524233', 'acronym': 'tDCS', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS)', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) For Improvement Of Cognitive Functioning, Brain Fog, And Working Memory', 'orgStudyIdInfo': {'id': '52200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Direct Stimulation', 'description': 'Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.', 'interventionNames': ['Device: Active Transcranial Direct Stimulation']}], 'interventions': [{'name': 'Active Transcranial Direct Stimulation', 'type': 'DEVICE', 'description': 'Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.', 'armGroupLabels': ['Transcranial Direct Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery, Baylor College of Medicine', 'investigatorFullName': 'Bijan Najafi, PhD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}