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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 adolescent depressive disorders.
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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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| dLPFC TI | Experimental | L_dLPFC TI Temporal Interference (TI) stimulation with 10 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| HAMD-17 | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | |
| HAMA | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | |
| MADRS | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | |
| PHQ-A | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | |
| GAD-7 | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | |
| SHAPS | Baseline, 4 weeks and 8 weeks | |
| PSQI | Baseline, 4 weeks and 8 weeks | |
| SF-36 | Baseline and 8 weeks | |
| WHOQOL-BREF | Baseline and 8 weeks | |
| ARI | Baseline and 8 weeks | |
| OSI | For use when the patient exhibits self-harming behavior | Baseline, 4 weeks and 8 weeks |
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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 | 18217122884 | 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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