Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-30 @ 12:28 PM
Study NCT ID:
NCT02904356
Status:
TERMINATED
Last Update Posted:
2019-11-25
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)
Sponsor:
Organization:
Raw JSON
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The intensity of stimulation will be based on resting-motor threshold (RMT).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brainsway H-coil for rTMS', 'description': 'Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.\n\nRepetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).'}], 'timeFrame': 'Up to 1 month', 'description': 'Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'PI left institution, no data was collected and analyzed in the specified manner.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brainsway H-coil for rTMS', 'description': 'Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.\n\nRepetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brainsway H-coil for rTMS', 'description': 'Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.\n\nRepetitive transcranial magnetic stimulation: High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis of Obsessive Compulsive Disorder', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-06', 'size': 688763, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-15T16:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'PI left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2016-08-25', 'resultsFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-06', 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response', 'timeFrame': 'Up to 1 month', 'description': 'Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['OCD', 'TMS', 'Neuromodulation', 'Obsessive-Compulsive Disorder', 'Transcranial Magnetic Stimulation', 'Imaging'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on brain imaging and neurophysiological measures of cognitive control in patients with Obsessive-Compulsive Disorder (OCD).', 'detailedDescription': 'With a prevalence of nearly 3%, obsessive-compulsive disorder (OCD) is one of the most common psychiatric disorders in the US. The first line of treatment for OCD comprises pharmacotherapy with serotonin reuptake inhibitors (SRIs) and cognitive behavioral therapy (CBT). Although adherence to these therapies has been shown to improve symptoms in at least half of patients, some have residual symptoms and a small percentage are refractory to standard therapies. Transcranial magnetic stimulation (TMS) may offer an alternate, less-invasive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary diagnosis of Obsessive Compulsive Disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID).\n* Subjects should have at least a moderate level of OCD severity as defined by a Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) score of ≥ 20.\n\nExclusion Criteria:\n\n* Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (expect nicotine and caffeine).\n* An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.\n* Individuals with a clinically defined neurological disorder including, but not limited to: stroke, tics, space occupying brain lesion, any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT), history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's Disease, Huntington Chorea, Multiple Sclerosis.\n* Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for \\>5 minutes.\n* History of treatment with rTMS therapy for any disorder.\n* History of treatment with Deep Brain Stimulation.\n* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.\n* Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.\n* Current illicit drug use."}, 'identificationModule': {'nctId': 'NCT02904356', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)', 'orgStudyIdInfo': {'id': 'AAAQ8771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brainsway H-coil for rTMS', 'description': 'Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.', 'interventionNames': ['Device: Repetitive transcranial magnetic stimulation']}], 'interventions': [{'name': 'Repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'otherNames': ['rTMS'], 'description': 'High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).', 'armGroupLabels': ['Brainsway H-coil for rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sameer Sheth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}