Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT05736458
Status:
TERMINATED
Last Update Posted:
2025-02-06
First Post:
2023-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Network Control TMS fMRI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oathes@pennmedicine.upenn.edu', 'phone': '215-573-9390', 'title': 'Dr. Desmond Oathes, Principal Investigator', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Enrollment goals were not completed due to delays resulting from COVID and not being granted a second no-cost extension.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from study enrollment until study completion (up to 3 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'High & Low Modal Controllability TMS Target in Non-symptomatic Participants', 'description': 'Non-symptomatic participants will complete 2 TMS/fMRI visits with alternate targets for a high and low modal controllability target.\n\nWe will administer TMS to an individualized target of high \\& low modal controllability while asymptomatic participant completes a working memory task inside the MRI scanner.\n\nTranscranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.\n\nHigh controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Modal Controllability TMS Target in ADHD Participants', 'description': 'We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.\n\nTranscranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.\n\nHigh controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache, dizziness, and nausea', 'notes': 'Subject reported headache, dizziness, and nausea during TMS/fMRI. TMS was stopped and subject withdrew from study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Minor Discomfort', 'notes': 'Subject reported weird feeling in ear while receiving rTMS inside the MRI.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4.44'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TMS to a High Controllability Target in Non-Symptomatic Participants', 'description': 'Non-symptomatic participants undergoing functional MRI (fMRI) interleaved with TMS to a high controllability region.'}, {'id': 'OG001', 'title': 'TMS to a Low Controllability Target in Non-Symptomatic Participants', 'description': 'Non-symptomatic participants undergoing functional MRI (fMRI) interleaved with TMS to a low controllability region.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.71', 'groupId': 'OG000', 'lowerLimit': '69.96', 'upperLimit': '89.45'}, {'value': '78.39', 'groupId': 'OG001', 'lowerLimit': '70.45', 'upperLimit': '86.33'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.45', 'groupDescription': "Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis. Statistics are from paired 2 tailed t-test comparing pre-rTMS 2-back percent accuracy scores for participant's high and low controllability target.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 weeks', 'description': 'Control participants complete two visits in which they undergo functional MRI interleaved with TMS targeting a specific controllability region. Each visit involves administering single pulses of TMS while participants perform a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while completing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high regional controllability target and the other stimulating a low regional controllability target.\n\nThe effect of single-pulse TMS on N-back task performance will be assessed before rTMS administration using percent accuracy scores. Percent accuracy reflects the percentage of correct trials out of the total Nback trials, with higher scores indicating better task performance.', 'unitOfMeasure': 'percentage of accuracy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 23 participants who completed all study procedures, 2 participants were unusable for this analysis.'}, {'type': 'PRIMARY', 'title': 'Effect of rTMS on Working Memory Task Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TMS to a High Controllability Target in Non-Symptomatic Participants', 'description': 'Non-symptomatic participants undergoing functional MRI (fMRI) interleaved with TMS to a high controllability region.'}, {'id': 'OG001', 'title': 'TMS to a Low Controllability Target in Non-Symptomatic Participants', 'description': 'Non-symptomatic participants undergoing functional MRI (fMRI) interleaved with TMS to a low controllability region.'}], 'classes': [{'title': 'Nback results Pre-rTMS', 'categories': [{'measurements': [{'value': '79.71', 'groupId': 'OG000', 'lowerLimit': '69.96', 'upperLimit': '89.45'}, {'value': '78.39', 'groupId': 'OG001', 'lowerLimit': '70.45', 'upperLimit': '86.33'}]}]}, {'title': 'Nback results Post-rTMS', 'categories': [{'measurements': [{'value': '81.65', 'groupId': 'OG000', 'lowerLimit': '73.40', 'upperLimit': '89.90'}, {'value': '84.75', 'groupId': 'OG001', 'lowerLimit': '77.57', 'upperLimit': '91.93'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.94', 'groupDescription': 'Statistics are from 2-tailed t-test comparing pre-rTMS to post-rTMS 2-back accuracy scores for a high controllability TMS target. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 19'}, {'pValue': '<0.04', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.36', 'groupDescription': 'Statistics are from 2-tailed t-test comparing pre-rTMS and post-rTMS 2-back percent accuracy scores for a low controllability TMS target. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 20'}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post-TMS at visits 3 (approximately day 7) and 4 (approximately day 14)', 'description': "Control participants complete two visits with functional MRI interleaved with TMS targeting a specific controllability region. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted controllability region is counterbalanced, with one visit stimulating a high controllability target and the other a low controllability target.\n\nThe effect of rTMS on N-back task performance will be assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy, indicating the percentage of correct trials, will be analyzed for both high and low regional controllability targets across the visits.", 'unitOfMeasure': 'percentage accuracy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis for the percent change comparison and high controllability group. Only 1 participant was unusable for the low controllability group."}, {'type': 'SECONDARY', 'title': 'Effect of rTMS on Working Memory Performance in Participants With ADHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TMS to a High Controllability Target in Participants With ADHD', 'description': 'Participants diagnosed with ADHD/ADD complete one visit involving functional MRI (fMRI) and TMS targeting a high controllability region. During this visit, participants receive single pulses of TMS while performing a working memory task (N-back), followed by repetitive TMS (rTMS), and then another round of single pulses while completing the N-back task. Unlike non-symptomatic subjects, ADHD participants do not have a separate visit with TMS to a low controllability target.'}], 'classes': [{'title': 'Nback results Pre-rTMS', 'categories': [{'measurements': [{'value': '69.64', 'groupId': 'OG000', 'lowerLimit': '57.21', 'upperLimit': '82.08'}]}]}, {'title': 'Nback results Post-rTMS', 'categories': [{'measurements': [{'value': '81.18', 'groupId': 'OG000', 'lowerLimit': '70.12', 'upperLimit': '92.25'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '11.54', 'groupDescription': 'Statistics are from 2-tailed paired t-test comparing 2-back accuracy score before and after rTMS to a high controllability target. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 11'}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post-TMS at visit 3 (approximately day 7)', 'description': "Participants with ADHD complete a single visit where they undergo functional MRI interleaved with TMS to a high controllability region. During the visit, participants receive single pulses of TMS while performing the working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while completing the N-back task.\n\nThe effect of rTMS on N-back task performance is assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy reflects the percentage of correct trials out of the total number of N-back trials, with higher percent accuracy indicating better performance.", 'unitOfMeasure': 'percentage of accuracy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 13 participants with ADHD that completed the study, 1 participant's data was unusable for this analysis."}, {'type': 'PRIMARY', 'title': 'Effect of rTMS to High vs. Low Controllability Target on Working Memory Task Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TMS to a High Controllability Target in Non-Symptomatic Participants', 'description': 'Non-symptomatic participants undergoing functional MRI (fMRI) interleaved with TMS to a high controllability region.'}, {'id': 'OG001', 'title': 'TMS to a Low Controllability Target in Non-Symptomatic Participants', 'description': 'Non-symptomatic participants undergoing functional MRI (fMRI) interleaved with TMS to a low controllability region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000', 'lowerLimit': '-3.11', 'upperLimit': '6.99'}, {'value': '6.36', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '12.16'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.42', 'groupDescription': "Statistics are from paired 2 tailed t-test comparing 2-back percent changes (Post-rTMS - pre-rTMS) scores for participant's high and low controllability target. Alternative hypothesis: true mean is not equal to 0.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 19'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 weeks', 'description': 'Control participants complete two visits where they undergo functional MRI interleaved with TMS targeting specific brain controllability regions. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high controllability target and the other a low controllability target.\n\nIn order to compare the effect of rTMS to high versus low controllability targets on working memory performance, we will assess the change in N-back task percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS to both regions. A greater percent change (positive value) means improved task performance following rTMS.', 'unitOfMeasure': 'percentage accuracy change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis for the percent change comparison and high controllability group. Only 1 participant was unusable for the low controllability group."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-symptomatic Participants High Modal Controllability First, Then Low Modal Controllability Target', 'description': 'Non-symptomatic participants will complete 2 TMS/fMRI visits, first receiving TMS to a high modal controllability target then the alternate low modal controllability target for the second TMS/fMRI.\n\nWe will administer TMS to an individualized target of high \\& low modal controllability while asymptomatic participant completes a working memory task inside the MRI scanner.\n\nTranscranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.\n\nHigh controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task.'}, {'id': 'FG001', 'title': 'Non-symptomatic Participants Low Modal Controllability First, Then High Modal Controllability Target', 'description': 'Non-symptomatic participants will complete 2 TMS/fMRI visits, first receiving TMS to a low modal controllability target then the alternate high modal controllability target for the second TMS/fMRI.\n\nWe will administer TMS to an individualized target of high \\& low modal controllability while asymptomatic participant completes a working memory task inside the MRI scanner.\n\nTranscranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.\n\nHigh controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task.'}, {'id': 'FG002', 'title': 'High Modal Controllability TMS Target in ADHD Participants', 'description': 'We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.\n\nTranscranial Magnetic Stimulation (TMS): Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.\n\nHigh controllability TMS target: Administer TMS to a brain regions with high modal controllability while the subject engages in a working memory task.'}], 'periods': [{'title': 'Baseline MRI and Assessments', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'TMS/fMRI #1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Washout (at Least 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'ADHD Participants only complete TMS/fMRI #1', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'TMS/fMRI #2 (Only for Non-symptomatic)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'ADHD Participants only complete TMS/fMRI #1', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the 68 participants screened for the study, 45 were enrolled and 23 did not start study procedures (13 screen failed, 4 withdrew from participation, and 6 lost to follow-up)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-symptomatic Participants', 'description': 'Non-symptomatic participants or those without any psychiatric history complete two visits involving functional MRI (fMRI) and TMS. Each visit targets a specific brain controllability region, with one visit focusing on a high controllability region and the other on a low controllability region.'}, {'id': 'BG001', 'title': 'ADHD Participants', 'description': 'Participants diagnosed with ADHD or ADD complete one visit involving functional MRI (fMRI) and TMS. This visit focuses exclusively on a high controllability brain region.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.96', 'spread': '2.89', 'groupId': 'BG000'}, {'value': '22.68', 'spread': '1.86', 'groupId': 'BG001'}, {'value': '22.84', 'spread': '2.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', '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': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', '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': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'E-SWAN ADHD scale', 'classes': [{'title': 'Inattentive ADHD Subscale', 'categories': [{'measurements': [{'value': '-1.310', 'spread': '0.730', 'groupId': 'BG000'}, {'value': '0.750', 'spread': '0.810', 'groupId': 'BG001'}, {'value': '-0.440', 'spread': '1.28', 'groupId': 'BG002'}]}]}, {'title': 'Hyperactive/Impulsive ADHD Subscale', 'categories': [{'measurements': [{'value': '-1.300', 'spread': '0.940', 'groupId': 'BG000'}, {'value': '0.550', 'spread': '0.840', 'groupId': 'BG001'}, {'value': '-0.520', 'spread': '1.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Extended Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (E-SWAN) was administered via survey on their baseline MRI to assess ADHD symptoms. This scale includes 18 items rated from -3 (far below average) to 3 (far above average), divided into two subscales: Inattention and Hyperactivity/Impulsivity. Average scores for each subscale are used to interpret results. An average score above 0.745 on a subscale indicates presence of ADHD symptoms, with higher scores reflecting more severe symptoms and negative scores suggesting fewer or no symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-23', 'size': 1410565, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-30T13:15', 'hasProtocol': True}, {'date': '2023-06-15', 'size': 668597, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-30T13:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This study will use a single-blind design.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All healthy participants will have TMS administered to both their high and low regional controllability targets, but the order is randomized and counterbalanced.\n\nADHD participants will have TMS administered to only their high regional controllability target.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'The study was terminated because our funding agency, the NIH, did not grant a no-cost extension to meet our recruitment goals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2023-01-19', 'resultsFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-14', 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance', 'timeFrame': 'Up to 3 weeks', 'description': 'Control participants complete two visits in which they undergo functional MRI interleaved with TMS targeting a specific controllability region. Each visit involves administering single pulses of TMS while participants perform a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while completing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high regional controllability target and the other stimulating a low regional controllability target.\n\nThe effect of single-pulse TMS on N-back task performance will be assessed before rTMS administration using percent accuracy scores. Percent accuracy reflects the percentage of correct trials out of the total Nback trials, with higher scores indicating better task performance.'}, {'measure': 'Effect of rTMS on Working Memory Task Performance', 'timeFrame': 'Pre- and post-TMS at visits 3 (approximately day 7) and 4 (approximately day 14)', 'description': "Control participants complete two visits with functional MRI interleaved with TMS targeting a specific controllability region. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted controllability region is counterbalanced, with one visit stimulating a high controllability target and the other a low controllability target.\n\nThe effect of rTMS on N-back task performance will be assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy, indicating the percentage of correct trials, will be analyzed for both high and low regional controllability targets across the visits."}, {'measure': 'Effect of rTMS to High vs. Low Controllability Target on Working Memory Task Performance', 'timeFrame': 'Up to 3 weeks', 'description': 'Control participants complete two visits where they undergo functional MRI interleaved with TMS targeting specific brain controllability regions. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high controllability target and the other a low controllability target.\n\nIn order to compare the effect of rTMS to high versus low controllability targets on working memory performance, we will assess the change in N-back task percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS to both regions. A greater percent change (positive value) means improved task performance following rTMS.'}], 'secondaryOutcomes': [{'measure': 'Effect of rTMS on Working Memory Performance in Participants With ADHD', 'timeFrame': 'Pre- and post-TMS at visit 3 (approximately day 7)', 'description': "Participants with ADHD complete a single visit where they undergo functional MRI interleaved with TMS to a high controllability region. During the visit, participants receive single pulses of TMS while performing the working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while completing the N-back task.\n\nThe effect of rTMS on N-back task performance is assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy reflects the percentage of correct trials out of the total number of N-back trials, with higher percent accuracy indicating better performance."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TMS', 'memory', 'ADHD', 'healthy', 'MRI', 'ADD'], 'conditions': ['Attention Deficit Hyperactivity Disorder', 'Attention Deficit Disorder', 'Working Memory']}, 'descriptionModule': {'briefSummary': 'This study uses different types of functional magnetic resonance imagining (fMRI) to generate individual transcranial magnetic stimulation (TMS) targets. During the TMS/fMRI imagining sessions, the investigators stimulate a target of either high or low regional controllability during a working memory task to investigate network responses and the impact of TMS on behavior.', 'detailedDescription': 'This study involves up to 4 visits for patients with Attention Deficit Hyperactivity Disorder (ADHD) and 5 visits for non-symptomatic subjects.\n\nVisit 1 has both remote and in-person procedures. The remote part of visit 1 will consist of a consenting and extended screening visit. The in-person procedures of visit 1 will be scheduled for the same day as visit 2. Before visit 2, the investigators will demonstrate TMS to make sure participants can tolerate the stimulation.\n\nVisit 2 consists of an hour-long baseline MRI Scan along with an assessment session. The baseline MRI scan is used to find individualized TMS targets. The assessment session of visit 2 will be done over a video call. During the video call, the investigators will have the participant complete some computerized tasks and assessments.\n\nVisit 3 will be a 1-hour long TMS/fMRI session, where the participant will complete a working memory task twice while single pulse TMS is being delivered. In between the 2 rounds of the working memory task, the participant will receive 4 minutes of repetitive stimulation.\n\nNon-symptomatic subjects will have a fourth visit that mirrors visit 3.\n\nVisit 5 or Visit 4 for ADHD participants, will take place if behavioral task is available, otherwise study participation will be considered complete. During the optional visit, participants may complete behavioral tasks during an MRI scan. No TMS will be administered during the final visit.\n\nParticipants will receive the compensation at the end of their participation. Payment may be given earlier if the participant withdraws from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-28 years old\n* Right-handed\n* No history of schizophrenia or bipolar disorder\n* No history of neurological illness\n* Healthy participants: no history of any mental illness\n* ADD/ADHD Participants; Diagnosed with ADD/ADHD\n* ADD/ADHD: Ability to refrain from stimulant medication within 24 hours of study sessions\n* For participants reporting daily use of more than 400mg caffeine/ day: willing to lower down to this level at least 1 week prior to screening visit and maintain throughout study visits\n\nExclusion Criteria:\n\n* Unable to have an MRI scan\n* Unable to receive or tolerate TMS\n* Pregnant, nursing, or trying to become pregnant (self-attestation alone)\n* History of stoke, epilepsy, or brain scarring\n* Healthy participants: psychoactive medication use\n* Healthy participants: first degree relative with psychosis\n* ADHD participants: inability to refrain from stimulant medication within 23 hours of study sessions\n* Active suicidality or current suicidal risk as determined by the investigator\n* Any medication that interferes with fMRI recordings as per PI discretion\n* Otherwise determined by investigator to be unfit for study'}, 'identificationModule': {'nctId': 'NCT05736458', 'briefTitle': 'Network Control TMS fMRI', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Network Control and Functional Context: Mechanisms for TMS Response', 'orgStudyIdInfo': {'id': '830174'}, 'secondaryIdInfos': [{'id': 'RF1MH116920', 'link': 'https://reporter.nih.gov/quickSearch/RF1MH116920', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High regional controllability TMS target in non-symptomatic participants', 'description': 'We will administer TMS to an individualized target of high regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)', 'Procedure: High controllability TMS target']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low controllability TMS target in non-symptomatic participants', 'description': 'We will administer TMS to an individualized target of low regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'High regional controllability TMS target in ADHD participants', 'description': 'We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)', 'Procedure: High controllability TMS target']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'description': 'Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.', 'armGroupLabels': ['High regional controllability TMS target in ADHD participants', 'High regional controllability TMS target in non-symptomatic participants', 'Low controllability TMS target in non-symptomatic participants']}, {'name': 'High controllability TMS target', 'type': 'PROCEDURE', 'description': 'Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.', 'armGroupLabels': ['High regional controllability TMS target in ADHD participants', 'High regional controllability TMS target in non-symptomatic participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}