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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amygdala TI | Experimental | Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nervio-X | Device | An 8-channel TIS device developed by NEURODOME Corporation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HAMD-17 | Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HAMA | HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings. | Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks |
| SHAPS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing HUANG, MD PhD | Contact | 021-68306699*1222 | jjhuang_att@163.com | |
| Chencheng Zhang, MD PhD | Contact | i@cczhang.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pudong New Area Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.
| Baseline, 4 weeks and 8 weeks |
| SF-36 | Baseline and 8 weeks |
| WHOQOL-BREF | Baseline and 8 weeks |
| PSQI | Baseline, 4 weeks and 8 weeks |
| THINC-it® | THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder | Baseline, treatment completion day and 8 weeks |
| Blood sample | 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 | Baseline, 4 weeks |
| GAD-7 | Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks |
| QIDS-SR | Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks |
| MADRS | Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks |