Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT07198594
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D003193', 'term': 'Compulsive Personality Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-17', 'size': 387932, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2025-09-21T22:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OCD Symptom Severity Assessed by Y-BOCS', 'timeFrame': 'From Baseline to 6 months after treatment', 'description': 'Change from Baseline to 4 weeks after treatment in OCD Symptom Severity'}], 'secondaryOutcomes': [{'measure': 'Safety for rTMS targeting IFC', 'timeFrame': 'Adverse Events after treatment', 'description': 'Number of Participants with Treatment-Related Adverse Events'}, {'measure': 'Depression Severity Assessed by HAMD', 'timeFrame': 'From baseline to 4 weeks after treatment'}, {'measure': 'Anxitey Severity Assessed by HAMA', 'timeFrame': 'From Baseline to 4 weeks after treatment'}, {'measure': 'Clinical Efficacy Assessed by CGI', 'timeFrame': 'From Baseline to 4 weeks after treatment'}, {'measure': 'Uncertainty Assessed by IUI and IUS-12', 'timeFrame': 'From Baseline to 4 weeks after treatment'}, {'measure': 'Self-rated Beck Depression Inventory (BDI)', 'timeFrame': 'From Baseline to 4 weeks after treatment'}, {'measure': 'Self-rated State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'From Baseline to 4 weeks after treatment'}, {'measure': 'Self-rated Short UPPS-P Impulsive Behaviour Scale', 'timeFrame': 'From baseline to 4 weeks after treatment'}, {'measure': 'Neuroimaging by Magnetic resonance imaging', 'timeFrame': 'From baseline to 4 weeks after treatment'}, {'measure': 'Cognitive Function Assessent by tasks', 'timeFrame': 'From baseline to 4 weeks after treatment', 'description': 'Including Cantab and coded tasks in Matlab'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obsessive Compulsive Disorder (OCD)', 'Obsessive - Compulsive Disorder']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. It will also learn about the safety of rTMS over right IFC. The main questions it aims to answer are:\n\n* Does rTMS using a new individualized IFC target relieve participants' OCD symptoms?\n* What medical problems do participants have when taking rTMS?\n\nParticipants will:\n\n* Take rTMS six times per day for 5 consecutive days\n* Visit the clinic once at baseline, the day and four weeks after treatment for checkups and tests"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria\n* without associated tics ("Gilles de la Tourette" Syndrome)\n* Age 18-60 years, right-handed\n* Disease severity: Yale-Brown Obsessive Compulsive Scale score ≥16 for OCD patients\n* Medication stable for at least 4 weeks\n* Resistant patients to standard treatments: partial but insufficient response (reduction of Y-BOCS score \\< 35%) or lack of response to previous well conducted treatment including: optimal tolerated dose and adequate duration (\\> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), or 1 Serotonin Reuptake Inhibitors + 1 augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone)\n* No systematic rTMS therapy in the past six months;\n* Signature of informed consent form;\n* Normal vision or corrected vision;\n* Capacity to complete protocol-specified tests.\n\nExclusion Criteria:\n\n* Abnormal cognitive status (assessed using MoCA with score \\<24);\n* Other primary diagnosis than OCD (comorbid mild depression is tolerated)\n* Comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance3)\n* Significant self-harm intent or severe suicidal tendencies within the past year;\n* Irreversible visual or auditory impairment preventing completion of scales or related assessments;\n* Presence of metallic implants, such as pacemakers or stents;\n* Any current or potential medical, psychological, social, or geographical factors compromising patient safety or study participation;\n* Poor compliance;\n* Claustrophobia;\n* History of epilepsy or familial epilepsy\n* Pregnant or lactating women (women of childbearing potential must obtain a negative pregnancy test result prior to study commencement and employ medically approved contraceptive measures);\n* Deterioration or failure of vital organ function (cardiac, pulmonary, hepatic, renal, etc.); or unstable vital signs;\n* Conditions unsuitable for this stimulation site, such as increased intracranial pressure, elevated intraocular pressure, or glaucoma\n* History of or concomitant neurological disorders: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington\'s disease and Parkinson\'s disease, Lewy body dementia, traumatic brain injury dementia, other physical/chemical factors (drugs, alcohol, CO, etc.), significant somatic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural haematoma, brain tumours), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiency or any other cause'}, 'identificationModule': {'nctId': 'NCT07198594', 'acronym': 'OCDTMS-IFC', 'briefTitle': 'Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University'}, 'officialTitle': 'A Study on the Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder and Its Underlying Neurological Mechanisms', 'orgStudyIdInfo': {'id': 'PDJW-KY-2025-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS', 'description': 'individualized rTMS targeting IFC, with symptom provocation', 'interventionNames': ['Other: rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'OTHER', 'description': 'individualized rTMS target the IFC with symptom provocation', 'armGroupLabels': ['rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200124', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruiqin Chen', 'role': 'CONTACT', 'email': 'chenrq@shspdjw.com', 'phone': '+86 13917451850'}], 'facility': 'Shanghai Pudong New Area Mental Health Centre', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yijie Zhao', 'role': 'CONTACT', 'email': 'yj_zhao@tongji.edu.cn', 'phone': '+86 13585960699'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'zhaoyijie', 'investigatorAffiliation': 'Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University'}}}}