[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647560":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":50,"centralContacts":58,"locations":49,"responsibleParty":67,"collaborators":70,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":49,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":49,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":112,"whyStopped":49,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":49},{"fullName":5,"class":6},"Central South University","OTHER",[8,14,18,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"MDD - High-frequency TI-tACS","EXPERIMENTAL","Participants in the MDD - High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (130Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala. The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.",[13],"Device: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)",{"label":15,"type":10,"description":16,"interventionNames":17},"MDD - Low-frequency TI-tACS","Participants in the MDD - Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (2 Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala. The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"MDD - Sham TI-tACS","SHAM_COMPARATOR","Participants in the MDD - Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.",[23],"Device: Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)",{"label":25,"type":10,"description":26,"interventionNames":27},"GAD - High-frequency TI-tACS","Participants in the GAD - High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (80Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala. The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.",[13],{"label":29,"type":10,"description":30,"interventionNames":31},"GAD - Low-frequency TI-tACS","Participants in the GAD - Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (5Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala. The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.",[13],{"label":33,"type":20,"description":34,"interventionNames":35},"GAD - Sham TI-tACS","Participants in the GAD - Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.",[23],[37,45],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)","Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.\n\nIn the MDD cohort, low-frequency stimulation will be delivered at 2 Hz and high-frequency stimulation at 130 Hz. In the GAD cohort, low-frequency stimulation will be delivered at 5 Hz and high-frequency stimulation at 80 Hz.",[25,29,9,15],[43,44],"Temporal Interference Stimulation (TIS)","Transcranial Temporal Interference Stimulation (tTIS)",{"type":38,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)","Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.",[33,19],null,[51,55],{"name":52,"affiliation":53,"role":54},"Yumeng Ju, PhD","Second Xiangya Hospital of Central South University","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":53,"role":57},"Yan Zhang, PhD","STUDY_CHAIR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":49,"email":63},"Yumeng Ju( Associate Researcher), PhD","CONTACT","86+18100731091","yumeng.ju@csu.edu.cn",{"name":65,"role":61,"phone":49,"phoneExt":49,"email":66},"Lingsi Zeng, PhD Candidate","zenglsi@163.com",{"type":54,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Yumeng Ju","Associate Investigator",[71,72,74,77,79,81],{"name":53,"class":6},{"name":73,"class":6},"Lanzhou University Second Hospital",{"name":75,"class":76},"Neuropsychiatric Institute of Fuzhou Second General Hospital","UNKNOWN",{"name":78,"class":76},"Affiliated Wuhan Mental Health Center of Huazhong University of Science and Technology",{"name":80,"class":76},"Affiliated WuTaiShan Hospital of Medical College of Yangzhou University",{"name":82,"class":76},"Xianyue Psychiatric Hospital, Xiamen","100647560","temporal-interference-transcranial-alternating-current-stimulation-for-major-depressive-disorder-and-generalized-anxiety-disorder-100647560",false,"NCT07712159","Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder and Generalized Anxiety Disorder","A Double-Blind, Randomized, Sham-Controlled Clinical Trial of Temporal Interference Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder and Generalized Anxiety Disorder","Inclusion Criteria:\n\n1. Age between 18 and 55 years (inclusive), any gender;\n2. Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;\n3. For MDD participants: HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose;\n4. For GAD participants: HAMA score ≥14; stable, regular medication for at least 2 months;\n5. Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;\n6. Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. History of psychiatric disorders other than MDD or GAD;\n2. Pregnancy or lactation;\n3. Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);\n4. History of significant head injury or coma\n5. Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment\n6. Suspected or confirmed history of alcohol or substance dependence;\n7. Current severe suicidal ideation or recent suicide attempt;\n8. Current participation in another clinical trial or recent use of prohibited psychotropic medications;\n9. Positive urine drug screening or abnormal thyroid function tests;\n10. Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);\n11. Inability to provide fully informed consent.","ALL","18 Years","55 Years",{"count":94,"type":95},192,"ESTIMATED","INTERVENTIONAL",[98],"NA","This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD).\n\nAll participants will be enrolled as two independent cohorts and randomized separately within each diagnostic group. Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala. Participants with generalized anxiety disorder will be randomized to receive high-frequency TI-tACS(80Hz), low-frequency TI-tACS(5Hz), or sham stimulation targeting the right amygdala.\n\nThe intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months.\n\nThe primary outcome for the MDD cohort is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. The primary outcome for the GAD cohort is the change from baseline in the Hamilton Anxiety Rating Scale (HAMA) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles in both the MDD and GAD cohorts.",[101,102],"Major Depressive Disorder (MDD)","Generalized Anxiety Disorder (GAD)",[104,105,106,107,108,109,110,111],"Major Depressive Disorder","Generalized Anxiety Disorder","Temporal Interference Transcranial Alternating Current Stimulation","Multi-center","Randomized Controlled Trial","Non-invasive brain stimulation","Neuromodulation","double-blind","NOT_YET_RECRUITING","2026-07-16",{"date":115,"type":116},"2026-07-17","ACTUAL",{"date":118,"type":95},"2026-06",{"date":120,"type":95},"2028-06",{"name":5,"class":6}]