Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT07065669
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm, randomized assignment to two types of transcranial magnetic stimulation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion rate', 'timeFrame': 'Baseline to completion of all protocol visits, up to 8 weeks', 'description': 'Proportion (percentage) of all participants who enter the study, undergo a minimum of one TMS treatment, and complete the protocol-specified 15 TMS visits'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline to completion of all protocol visits up to 8 weeks', 'description': 'Frequency (percentage) of individual adverse events'}], 'secondaryOutcomes': [{'measure': 'Combined efficacy', 'timeFrame': 'Baseline to completion of all protocol visits, up to 8 weeks', 'description': 'Change in independent assessor-rated CY-BOCS II total score'}, {'measure': 'Site efficacy', 'timeFrame': 'From screening to end of treatment (Week 4)', 'description': 'Compare changes in blinded clinician CY-BOCS II total by TMS site (OFC vs dmPFC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Adolescent', 'transcranial magnetic stimulation'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '39293504', 'type': 'BACKGROUND', 'citation': 'Vicheva P, Osborne C, Krieg SM, Ahmadi R, Shotbolt P. Transcranial magnetic stimulation for obsessive-compulsive disorder and post-traumatic stress disorder: A comprehensive systematic review and analysis of therapeutic benefits, cortical targets, and psychopathophysiological mechanisms. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jan 10;136:111147. doi: 10.1016/j.pnpbp.2024.111147. Epub 2024 Sep 16.'}, {'pmid': '31109199', 'type': 'BACKGROUND', 'citation': 'Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.'}]}, 'descriptionModule': {'briefSummary': "This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating adolescents with Obsessive Compulsive Disorder (OCD) who have experienced limited improvements with usual treatments for OCD in adolescents.\n\nThe project's primary goal is to examine whether adolescents can complete 3 consecutive weeks of TMS administered 5 days per week, and to describe the type of and how common individual side effects with TMS occur in adolescents with OCD.\n\nParticipants will:\n\n* visit the clinic every weekday for 3 weeks (15 days) to receive TMS treatments\n* have a brain MRI scan before TMS treatments begins and after finishing all TMS\n* complete questionnaires and report changes in behavior and physical symptoms", 'detailedDescription': "This study's primary goal is to examine whether treatment with two forms of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) show acceptable tolerability, safety, and preliminary signals of efficacy for adolescents with Obsessive Compulsive Disorder (OCD) that has not responded satisfactorily to 1st line treatments. While TMS is FDA-approved for OCD in adults, data on TMS in youth with OCD is limited. Results will inform on how suitable TMS treatment is for adolescents with OCD, and guide future, larger studies.\n\nThe study is considered a randomized, single blind, clinical trial.\n\nThe design of the study is a two-group parallel comparative study of two different TMS stimulation sites, the orbito-frontal cortex (OFC) and the dorsal medial prefrontal cortex (dmPFC).\n\nModel description: both groups will receive active TMS treatment sessions in clinic every weekday for 3 consecutive weeks (15 days). During each TMS session, participants in both groups will receive 3 TMS stimulations separated by a rest period, for a total of 45 individual TMS treatments. Study participants will receive TMS to only their assigned stimulation site.\n\nNumber of arms: there are two treatment arms based on assigned treatment site, an OFC arm and a dmPFC arm.\n\nMasking: an independent evaluator will be masked to treatment arm assignment and adverse events. All other study personnel will not be masked.\n\nAllocation: participants will be randomly assigned to group according to a computer-generated assignment schedule.\n\nEnrollment: total planned enrollment is 30 eligible participants who are randomized.\n\nArm Information:\n\nArm titles-- orbitofrontal cortex (OFC) and dorsal medial prefrontal cortex (dmPFC) Arm types: the dmPFC arm is considered the intervention arm; the OFC arm is considered the active comparator arm.\n\nInterventions:\n\nIntervention type: Device (both arms)\n\nIntervention name(s):\n\nOFC - continuous theta burst stimulation (cTBS) dmPFC - intermittent theta burst stimulation (iTBS)\n\nIntervention description:\n\nOFC - three stimulations per day of 1,800 pulses/stimulation cTBS for 15 days dmPFC - three stimulations per day of 1,800 pulses/session iTBS for 15 days"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. outpatients\n2. ages 13 - 17 years\n3. meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score \\> 16 (moderate to severe).\n4. stable on chronic psychotropic medications and/or therapy for 8 weeks prior to the study and agreeable to continue throughout the study without changes.\n5. participants may continue to take medications and record daily usage throughout the study.\n6. capacity to provide informed assent and parent or legal guardian able to provide consent.\n7. ability to tolerate clinical study procedures.\n8. successfully complete the screening forms without any contraindications.\n\nExclusion Criteria:\n\n1. Psychiatric: history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT.\n2. Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis, frank brain injury).\n3. TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk; family history of 1st degree relative with seizure disorder.\n4. Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, malnutrition secondary to eating disorder).\n5. Females who are pregnant or nursing (as determined by a questionnaire and pregnancy test).\n6. Current and anticipated continued treatment with excluded medication (See prohibited list).\n7. Inability to complete the research protocol as determined by the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT07065669', 'briefTitle': 'Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation', 'orgStudyIdInfo': {'id': '24-41216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Right Orbitofrontal TBS', 'description': 'continuous theta burst stimulation', 'interventionNames': ['Device: cTBS to ROFC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TBS of dorsal, medial prefrontal cortex', 'description': 'intermittent theta burst stimulation (iTBS) will be delivered to the dmPFC', 'interventionNames': ['Device: Dorsal medial Prefrontal Cortex intermittent theta burst stimulation']}], 'interventions': [{'name': 'Dorsal medial Prefrontal Cortex intermittent theta burst stimulation', 'type': 'DEVICE', 'description': 'iTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD', 'armGroupLabels': ['TBS of dorsal, medial prefrontal cortex']}, {'name': 'cTBS to ROFC', 'type': 'DEVICE', 'description': 'continuous theta burst stimulation (cTBS) 1,800 pulses per session', 'armGroupLabels': ['Right Orbitofrontal TBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Starlette Khim, BA', 'role': 'CONTACT', 'email': 'ocdteenTMS@ucsf.edu', 'phone': '415-514-5743'}, {'name': 'James T McCracken, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Starlette Khim, BA', 'role': 'CONTACT', 'email': 'ocdteenTMS@ucsf.edu', 'phone': '415-514-5743'}], 'overallOfficials': [{'name': 'James T McCracken, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning one year and ending 3 years after publication of results', 'ipdSharing': 'YES', 'description': 'IPD to be shared will include both primary endpoint data and secondary endpoint data.', 'accessCriteria': 'Qualified researchers who submit a brief description of planned analyses must be submitted to the PI to review and approve data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hearst Foundations', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}