Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT04130958
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Functional Connectivity of Key Nodes', 'timeFrame': 'Through Treatment Completion, Average of 3 Days', 'description': 'Measured using Magnetic Resonance Imaging'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Magnetic Stimulation', 'Intermittent Theta Burst'], 'conditions': ['Major Depressive Episode', 'Borderline Personality Disorder', 'Suicide']}, 'descriptionModule': {'briefSummary': 'This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).', 'detailedDescription': 'This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* Diagnosed with BPD or MDE\n* Chief complaint of suicidal thoughts and behaviors\n\nExclusion Criteria:\n\n* Neurological conditions with known structural brain lesion\n* Prior neurosurgical procedure\n* Metal in the body that is ferromagnetic or metal injury to the eyes\n* Epilepsy\n* Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt\n* Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)\n* Current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report\n* Inability to meet the safety criteria for MRI scanning according to the protocols of the MGH Department of Radiology\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT04130958', 'briefTitle': 'Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics', 'orgStudyIdInfo': {'id': '2019P002288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDE and Active iTBS-TMS', 'description': 'This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.', 'interventionNames': ['Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)']}, {'type': 'EXPERIMENTAL', 'label': 'BPD and Active iTBS-TMS', 'description': 'This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.', 'interventionNames': ['Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)']}, {'type': 'SHAM_COMPARATOR', 'label': 'MDE and Sham iTBS-TMS', 'description': 'This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.', 'interventionNames': ['Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)']}, {'type': 'SHAM_COMPARATOR', 'label': 'BPD and Sham iTBS-TMS', 'description': 'This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.', 'interventionNames': ['Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)']}], 'interventions': [{'name': 'Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)', 'type': 'DEVICE', 'otherNames': ['Active iTBS-TMS'], 'description': 'iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.', 'armGroupLabels': ['BPD and Active iTBS-TMS', 'MDE and Active iTBS-TMS']}, {'name': 'Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)', 'type': 'DEVICE', 'otherNames': ['Sham iTBS-TMS'], 'description': 'The sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents.', 'armGroupLabels': ['BPD and Sham iTBS-TMS', 'MDE and Sham iTBS-TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'DNN Inbox', 'role': 'CONTACT', 'email': 'mghdnn@mgh.harvard.edu', 'phone': '6177248780'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'DNN Inbox', 'role': 'CONTACT', 'email': 'mghdnn@mgh.harvard.edu', 'phone': '6177248780'}], 'overallOfficials': [{'name': 'Joan Camprodon, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '6177265348'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation', 'investigatorFullName': 'Joan A Camprodon, MD MPH PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}