Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
Study NCT ID:
NCT04014959
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2019-07-01
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mini Theta Burst TMS in MDD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data was collected from study enrollment until study completion (Up to 3 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All participants follow the same procedures.\n\nTMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.\n\nAgain, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 5, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting during TMS/fMRI scan', 'notes': 'Participant threw up during TMS/ fMRI scan and said it was due to not eaten all day; after they ate crackers they insisted on finishing rest of scan and had no further issues. Though rare, nausea is listed as a possible side effect of TMS.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety during TMS/fMRI scan', 'notes': 'Subject reported anxiety during TMS/ fMRI scan. Participant took a 15min break and then decided to finish scan.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emotional Discomfort during assessment', 'notes': 'Patient complained of emotional discomfort following the Columbia-Suicide Severity Rating Scale (C-SSRS).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Faint', 'notes': "Subject had a brief feeling of 'blacking out' and faint feeling during TMS stimulation. Subject was withdrawn from the study for safety.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cutis verticis gyrata (CVG)', 'notes': 'After completing the structural scan (T1) staff noticed that subject had unsual folds in their scalp. They were referred to a radiologist who determined they had CVG.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Enrolled Participants', 'description': 'All participants follow the same procedures.\n\nTMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.'}], 'classes': [{'title': 'Pre-tx/Pre-iTBS', 'categories': [{'measurements': [{'value': '-0.2684097', 'groupId': 'OG000', 'lowerLimit': '-0.3902711', 'upperLimit': '-0.1465483'}]}]}, {'title': 'Pre-tx/Post-iTBS', 'categories': [{'measurements': [{'value': '-0.1897918', 'groupId': 'OG000', 'lowerLimit': '-0.31831449', 'upperLimit': '-0.06126901'}]}]}, {'title': 'Post-tx/Pre-iTBS', 'categories': [{'measurements': [{'value': '-0.2640429', 'groupId': 'OG000', 'lowerLimit': '-0.44510461', 'upperLimit': '-0.08298111'}]}]}, {'title': 'Post-tx/Post-iTBS', 'categories': [{'measurements': [{'value': '-0.4190647', 'groupId': 'OG000', 'lowerLimit': '-0.5876522', 'upperLimit': '-0.2504772'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 't(35)= -4.47'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 't(35)= -3.00'}, {'pValue': '0.005', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 't(35)= -2.96'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 't(35)= -5.05'}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Change in subgenual anterior cingulate evoked response (fMRI BOLD) at all four timepoints across the two TMS/fMRI scan sessions: pre-intervention and preceding a single round of iTBS in the scanner (pre-tx, pre-iTBS); pre-intervention, following single iTBS in the scanner (pre-tx, post-iTBS); post intervention, preceding iTBS in the scanner (post-tx, pre-iTBS); and post-intervention, post-iTBS in the scanner (post-tx, post-iTBS).\n\nGreater negative change is associated with more clinical improvement.', 'unitOfMeasure': '% BOLD signal change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 37 participants who completed all study procedures, the data from 36 participants was analyzed. Data one subject was not usable.'}, {'type': 'SECONDARY', 'title': 'Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants follow the same procedures.\n\nTranscranial Magnetic Stimulation: 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. Repetitive TMS (rTMS) is FDA-approved for depression treatment.\n\nTMS is administered over 5 study visits: an initial TMS/fMRI session, a 3-day TMS intervention regimen, and a post-intervention TMS/fMRI session. During TMS/fMRI sessions, participants receive single pulses of TMS pre/post a short round of Intermittent Theta Burst Stimulation (iTBS), a modified rTMS protocol. Throughout the 3-day intervention regimen, participants receive two full rounds of iTBS daily.\n\nAll study participants receive active TMS.'}], 'classes': [{'title': 'Pre 3-day TMS intervention', 'categories': [{'measurements': [{'value': '26.78', 'spread': '1.566064', 'groupId': 'OG000'}]}]}, {'title': 'Post 3-day TMS intervention', 'categories': [{'measurements': [{'value': '17.61', 'spread': '2.012374', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to one week', 'description': 'The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report tool with 21 items, assessing depression, anxiety, and stress levels. The scale scores range from 0 to 63, with higher scores indicating more severe or frequent emotional symptoms. The change in DASS-21 score will be evaluated pre and post the 3-day TMS Intervention Regimen.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 37 participants who completed all study procedures, the data of one subject was unusable. Therefore, the data of 36 participants was used for analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Evoked Functional Brain Activity Before and After the 3-Day TMS Intervention Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants follow the same procedures. Transcranial Magnetic Stimulation: 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. Repetitive TMS (rTMS) is FDA-approved for depression treatment.\n\nTMS is administered over 5 study visits: an initial TMS/fMRI session, a 3-day TMS intervention regimen, and a post-intervention TMS/fMRI session. During TMS/fMRI sessions, participants receive single pulses of TMS pre/post a short round of Intermittent Theta Burst Stimulation (iTBS), a modified rTMS protocol. Throughout the 3-day intervention regimen, participants receive two full rounds of iTBS daily.\n\nAll study participants receive active TMS.'}], 'classes': [{'title': 'Pre 3-day TMS intervention', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.063308', 'groupId': 'OG000'}]}]}, {'title': 'Post 3-day TMS intervention', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.083043', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': 'Analysis to investigate the correlation between changes in DASS-21 Scores (Secondary Outcome) and Evoked Functional Brain Activity (Other Pre-specified Outcome) pre and post the 3-Day TMS Intervention Regimen.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'β = -33.60', 'nonInferiorityComment': 'Statistics are an unadjusted linear regression of change in DASS-21 depression score on the pre-intervention TMS/fMRI evoked brain response.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to one week', 'description': 'Change in subgenual anterior cingulate evoked response (fMRI BOLD) Before and After the 3-Day TMS Intervention Regimen\n\nGreater negative change is associated with more clinical improvement.', 'unitOfMeasure': '% BOLD signal change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 37 participants who completed all study procedures, the data of one subject was unusable. Therefore, the data of 36 participants was used for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All participants follow the same procedures.\n\nTMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.\n\nAgain, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.'}], 'periods': [{'title': 'Baseline MRI and Assessments', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Targeting TMS Scan', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'TMS + fMRI Scan #1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Mini TMS Sessions (3 Visits)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'TMS + fMRI Scan #2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the 86 subjects screened for the study, 41 were enrolled and 45 did not start study procedures (32 screen failed, 9 withdrew from participation, and 4 lost to follow-up).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants follow the same procedures.\n\nTMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.\n\nAgain, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.9', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender Now', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Snaith-Hamilton Pleasure Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.84', 'spread': '3.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The SHAPS (Snaith et al, 1995) is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only analyzed participants who completed all study procedures.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-16', 'size': 783436, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-18T13:21', 'hasProtocol': True}, {'date': '2020-12-16', 'size': 371847, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-05-18T13:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects receive active TMS to their individualized fMRI-guided target. Participants will first receive TMS in the MRI scanner, then over the course of 3-Day TMS Intervention Regimen, and lastly in a final MRI scan.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2019-07-01', 'resultsFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-05', 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Evoked Functional Brain Activity Before and After the 3-Day TMS Intervention Regimen', 'timeFrame': 'Up to one week', 'description': 'Change in subgenual anterior cingulate evoked response (fMRI BOLD) Before and After the 3-Day TMS Intervention Regimen\n\nGreater negative change is associated with more clinical improvement.'}], 'primaryOutcomes': [{'measure': 'Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen', 'timeFrame': '5 days', 'description': 'Change in subgenual anterior cingulate evoked response (fMRI BOLD) at all four timepoints across the two TMS/fMRI scan sessions: pre-intervention and preceding a single round of iTBS in the scanner (pre-tx, pre-iTBS); pre-intervention, following single iTBS in the scanner (pre-tx, post-iTBS); post intervention, preceding iTBS in the scanner (post-tx, pre-iTBS); and post-intervention, post-iTBS in the scanner (post-tx, post-iTBS).\n\nGreater negative change is associated with more clinical improvement.'}], 'secondaryOutcomes': [{'measure': 'Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen', 'timeFrame': 'Up to one week', 'description': 'The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report tool with 21 items, assessing depression, anxiety, and stress levels. The scale scores range from 0 to 63, with higher scores indicating more severe or frequent emotional symptoms. The change in DASS-21 score will be evaluated pre and post the 3-day TMS Intervention Regimen.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['depression', 'TMS', 'fMRI'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This is not a treatment study.\n\nIn this study, the researchers are primarily interested in examining whether functional MRI (fMRI)-guided transcranial magnetic stimulation (TMS) may be more effective than traditional TMS methods at temporarily influencing neural circuit communication. The investigators test this by combining TMS and fMRI technologies to probe and modulate brain activity.\n\nIf the novel fMRI-guided TMS stimulation used in this study is more effective than traditional methods, future studies may utilize similar personalized TMS targeting methods to yield even better clinical outcomes.', 'detailedDescription': "This study will involve a baseline Magnetic Resonance Imaging (MRI) scan, Transcranial Magnetic Stimulation (TMS), and TMS interleaved with functional MRI (fMRI) scans.\n\nAfter screening, eligible participants will undergo a 1-hour MRI scan, encompassing structural and functional scans to establish TMS stimulation targets for subsequent visits. During the baseline TMS/fMRI session or pre-intervention TMS/fMRI, single pulses of TMS and a short round of repetitive TMS (rTMS) will be administered to the participant's individualized target while functional MRI scans (fMRI) are collected. Following this, participants will commence a short TMS intervention regimen involving daily rTMS over 3 consecutive days. The day after the intervention, participants will undergo another TMS/fMRI session, or the post-intervention TMS/fMRI, to capture potential changes from the 3-day intervention.\n\nClinical assessments will be conducted at baseline before the first TMS/fMRI session and again after the final TMS/fMRI session to assess symptom changes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 60 years old, inclusive\n* Right-handed\n* Currently experiencing a major depressive episode (MDD)\n* Capacity to give informed consent and follow study procedures\n* Command of English language to understand/ respond to written and verbal instructions\n\nExclusion Criteria:\n\n* MRI contraindications (i.e., metal in body, claustrophobia, etc.)\n* TMS contraindications (i.e., seizure disorder)\n* Diagnosis of exclusionary psychiatric disorder (i.e., schizophrenia, bipolar)\n* Current use of psychiatric medication and unable/ willing to safely withdraw\n* Refusal to abstain from alcohol or drugs for duration of study\n* Medication use that reduces seizure threshold\n* Medication that interferes with blood flow (i.e., opioids, antihypertensive)\n* Known neurological disorder or significant disability that interferes with study procedures\n* Woman who is pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04014959', 'acronym': 'NARSAD', 'briefTitle': 'Mini Theta Burst TMS in MDD Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Mini Theta Burst TMS to Promote Brain Plasticity Indexed by fMRI in MDD Patients', 'orgStudyIdInfo': {'id': '825761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Participants', 'description': 'All participants follow the same procedures.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', '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. Repetitive TMS (rTMS) is FDA-approved for depression treatment.\n\nTMS is administered over 5 study visits: an initial TMS/fMRI session, a 3-day TMS intervention regimen, and a post-intervention TMS/fMRI session. During TMS/fMRI sessions, participants receive single pulses of TMS pre/post a short round of Intermittent Theta Burst Stimulation (iTBS), a modified rTMS protocol. Throughout the 3-day intervention regimen, participants receive two full rounds of iTBS daily.\n\nAll study participants receive active TMS.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Desmond Oathes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Desmond Oathes', 'investigatorAffiliation': 'University of Pennsylvania'}}}}