Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:27 PM
Study NCT ID:
NCT06461260
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amygdala MRI-TIS for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAMD-17', 'timeFrame': 'Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'HAMA', 'timeFrame': 'Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks', 'description': 'HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings.'}, {'measure': 'SHAPS', 'timeFrame': 'Baseline, 4 weeks and 8 weeks', 'description': 'The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.'}, {'measure': 'SF-36', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'WHOQOL-BREF', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'PSQI', 'timeFrame': 'Baseline, 4 weeks and 8 weeks'}, {'measure': 'THINC-it®', 'timeFrame': 'Baseline, treatment completion day and 8 weeks', 'description': 'THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder'}, {'measure': 'Blood sample', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Peripheral blood will be collected at baseline and one 4 weeks after treatment for transcriptomic and proteomic studies to explore the molecular mechanisms of temporal interference (TI) in the treatment of depressive disorders and to identify molecular markers for predicting therapeutic efficacy'}, {'measure': 'GAD-7', 'timeFrame': 'Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks'}, {'measure': 'QIDS-SR', 'timeFrame': 'Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks'}, {'measure': 'MADRS', 'timeFrame': 'Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Deep Brain Stimulation', 'TI stimulation'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be aged between 18 and 65, with no gender restrictions;\n* A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);\n* HAMD-17 score of 17 or higher;\n* Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;\n* Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form.\n\nExclusion Criteria:\n\n* Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy;\n* Participants must not have a history of seizures or prior episodes of epilepsy;\n* The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;\n* Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention;\n* Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);\n* The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;\n* Pregnant or breastfeeding;\n* Participants who are concurrently engaged in other clinical interventional trials;\n* Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied"}, 'identificationModule': {'nctId': 'NCT06461260', 'briefTitle': 'Amygdala MRI-TIS for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University'}, 'officialTitle': 'Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression', 'orgStudyIdInfo': {'id': 'PDJW-2024-001CSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amygdala TI', 'description': 'Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.', 'interventionNames': ['Device: Nervio-X']}], 'interventions': [{'name': 'Nervio-X', 'type': 'DEVICE', 'description': 'An 8-channel TIS device developed by NEURODOME Corporation.', 'armGroupLabels': ['Amygdala TI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingjing Huang', 'role': 'CONTACT', 'phone': '021-68306699*1222'}], 'facility': 'Shanghai Pudong New Area Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jingjing HUANG, MD PhD', 'role': 'CONTACT', 'email': 'jjhuang_att@163.com', 'phone': '021-68306699*1222'}, {'name': 'Chencheng Zhang, MD PhD', 'role': 'CONTACT', 'email': 'i@cczhang.org'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Jingjing Huang, MD', 'investigatorAffiliation': 'Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University'}}}}