Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03259568
Status:
TERMINATED
Last Update Posted:
2023-03-29
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of rTMS on Human Brain Activity Measured With fMRI
Sponsor:
Organization:
Raw JSON
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'paramType': 'MEAN', 'timeFrame': 'during each TMS session, up to 3 hours', 'description': 'Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal', 'unitOfMeasure': 'BOLD activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Within-subjects manipulation (same subjects for each condition).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active rTMS', 'description': 'Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Participant performance was low', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active rTMS (Repetitive Transcranial Magnetic Stimulation)', 'description': 'Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '2.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Within-subjects design, each subject received four TMS conditions ("arms").'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', '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': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Within-subjects design, all conditions ("arms") were repeated in each of the 27 participants.'}, {'title': 'fMRI Activity', 'classes': [{'title': '20% RMT', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.14', 'groupId': 'BG000'}]}]}, {'title': '40% RMT', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.12', 'groupId': 'BG000'}]}]}, {'title': '80% RMT', 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.14', 'groupId': 'BG000'}]}]}, {'title': '120% RMT', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measure reflects TMS-evoked activity associated with each TMS Intensity condition ("arm"), i.e., 20%, 40%, 80%, and 120% of an individualized resting motor threshold.', 'unitOfMeasure': 'BOLD response', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Study used a within-subjects design; all 27 participants received all 4 conditions ("arms") of TMS stimulation.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-23', 'size': 483394, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-14T11:52', 'hasProtocol': True}, {'date': '2022-03-16', 'size': 141790, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-26T13:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant is not informed about TMS intensity.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study ("arms") are repeated within each participant (20%, 40%, 80%, or 120% of an individual\'s titrated resting motor threshold).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Slow enrollment due to Covid-19.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2022-01-24', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2017-08-15', 'resultsFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2017-08-21', 'dispFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-03', 'studyFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion Perception Accuracy', 'timeFrame': 'during each TMS session, up to 3 hours', 'description': 'Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)'}, {'measure': 'Reaction Time', 'timeFrame': 'during each TMS session, up to 3 hours', 'description': 'Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)'}, {'measure': 'Activation of Cortical Networks During a Visual Motion Task.', 'timeFrame': 'during each TMS session, up to 3 hours', 'description': 'Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TMS', 'BOLD activity', 'Network activity'], 'conditions': ['Human Brain Activity']}, 'descriptionModule': {'briefSummary': 'This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 18-30.\n2. Use of effective method of birth control for women of childbearing capacity.\n3. Willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).\n2. Current serious medical illness (self report).\n3. History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator); \\[TMS Adult Safety Screening (TASS) form\\].\n4. Subjects are unable or unwilling to give informed consent.\n5. Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)\n6. Subjects with a clinically defined neurological disorder including, but not limited to:\n\n 1. Any condition likely to be associated with increased intracranial pressure\n 2. Space occupying brain lesion.\n 3. History of stroke.\n 4. Transient ischemic attack within two years.\n 5. Cerebral aneurysm.\n 6. Dementia.\n 7. Mini Mental Status Exam (MMSE) score of \\<24.\n 8. Parkinson's disease.\n 9. Huntington's disease.\n\n i. Multiple sclerosis.\n7. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.\n8. Subjects with cochlear implants\n9. Subjects not willing to tolerate the confinement associated with being in the MRI scanner.\n10. Women who are pregnant or breast-feeding (urine test).\n11. Blindness.\n12. Inability to read or understand English."}, 'identificationModule': {'nctId': 'NCT03259568', 'briefTitle': 'Effects of rTMS on Human Brain Activity Measured With fMRI', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effects of rTMS on Human Brain Activity Measured With fMRI', 'orgStudyIdInfo': {'id': 'Pro00082433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-response TMS - Intensity = 20%RMT', 'description': 'Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.\n\nOutcome measures include accuracy, RT, and BOLD signal.', 'interventionNames': ['Device: Repetitive TMS']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-response TMS - Intensity = 40%RMT', 'description': 'Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.\n\nOutcome measures include accuracy, RT, and BOLD signal.', 'interventionNames': ['Device: Repetitive TMS']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-response TMS - Intensity = 80%RMT', 'description': 'Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.\n\nOutcome measures include accuracy, RT, and BOLD signal.', 'interventionNames': ['Device: Repetitive TMS']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-response TMS - Intensity = 120%RMT', 'description': 'Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.\n\nOutcome measures include accuracy, RT, and BOLD signal.', 'interventionNames': ['Device: Repetitive TMS']}], 'interventions': [{'name': 'Repetitive TMS', 'type': 'DEVICE', 'description': '1-10 Hertz rTMS will be administered', 'armGroupLabels': ['Dose-response TMS - Intensity = 120%RMT', 'Dose-response TMS - Intensity = 20%RMT', 'Dose-response TMS - Intensity = 40%RMT', 'Dose-response TMS - Intensity = 80%RMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}