Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-11 @ 5:02 PM
Study NCT ID:
NCT05443256
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2022-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TMS Alteration of the Reward Positivity
Sponsor:
Organization:
Raw JSON
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Cavanagh', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'dlPFC Stimulation', 'description': 'To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. Based on our working hypothesis, TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.\n\nTranscranial Magnetic Stimulation: Figure 8 coil stimulation', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'dmPFC Stimulation', 'description': 'To stimulate individualized targets in dmPFC to alter affective modulation of the RewP. Based on our working hypothesis, TMS Deep Cone stimulation should boost learning-related modulation of RewP amplitude when compared to sham.\n\nTranscranial Magnetic Stimulation: Deep Cone stimulation', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reward Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'dlPFC Stimulation', 'description': 'To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. Based on our working hypothesis, TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.\n\nTranscranial Magnetic Stimulation: Figure 8 coil stimulation'}, {'id': 'OG001', 'title': 'dmPFC Stimulation', 'description': 'To stimulate individualized targets in dmPFC to alter affective modulation of the RewP. Based on our working hypothesis, TMS Deep Cone stimulation should boost learning-related modulation of RewP amplitude when compared to sham.\n\nTranscranial Magnetic Stimulation: Deep Cone stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '.29', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During intervention', 'description': 'EEG Amplitude 200-400 ms following reward receipt', 'unitOfMeasure': 'femtoteslas', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Theta Stim', 'description': 'To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. 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The Reward Positivity should be unaffected.\n\nTranscranial Magnetic Stimulation: Figure 8 coil stimulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'dlPFC Stimulation', 'description': 'To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. 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Based on our working hypothesis, TMS Deep Cone stimulation should boost learning-related modulation of RewP amplitude when compared to sham.\n\nTranscranial Magnetic Stimulation: Deep Cone stimulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.75', 'spread': '5.12', 'groupId': 'BG000'}, {'value': '29.75', 'spread': '3.77', 'groupId': 'BG001'}, {'value': '27.75', 'spread': '4.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-24', 'size': 344701, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-06T13:17', 'hasProtocol': True}, {'date': '2022-02-24', 'size': 115853, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-05T12:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two separate arms of study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2022-06-29', 'resultsFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-05', 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reward Positivity', 'timeFrame': 'During intervention', 'description': 'EEG Amplitude 200-400 ms following reward receipt'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anhedonia']}, 'descriptionModule': {'briefSummary': 'The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP).', 'detailedDescription': 'The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP). The RewP is a sensitive and specific biomarker of reward receipt. This proposal will advance a causal test of the hypothesis that there are two major sources of variance that contribute to this brain response: a dorsal midline contribution to information encoding and a ventral midline contribution that is modulated by affect. Together, these findings will reveal how the RewP acts to blend multiple aspects of value together in the service of motivated learning. The objective of this proposal is to gather pilot data to demonstrate the feasibility of using transcranial magnetic stimulation (TMS) to perturb idiosyncratically-defined (fMRI-based) dorsal or ventral targets in order to causally test the hypothesis that these different sources contribute different types of variance to the RewP. TMS double cone deep coil stimulation should diminish +RPE encoding in the RewP when compared to sham. TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Men or women aged 18-30\n\nExclusion Criteria:\n\n* Participants unwilling or unable to give informed consent\n* Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study\n* MEG/MRI contraindications\n* History of psychosis\n* Not fluent in English"}, 'identificationModule': {'nctId': 'NCT05443256', 'briefTitle': 'TMS Alteration of the Reward Positivity', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Causal Dissociation of Value Contributions to the Reward Positivity', 'orgStudyIdInfo': {'id': '20071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theta Stim', 'description': 'To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. Based on our working hypothesis, TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Stim', 'description': 'Sham stimulation. The Reward Positivity should be unaffected.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Figure 8 coil stimulation', 'armGroupLabels': ['Sham Stim', 'Theta Stim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico - Logan hall', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'James Cavanagh', 'investigatorAffiliation': 'University of New Mexico'}}}}