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| Name | Class |
|---|---|
| Tianjin Anding Hospital | OTHER |
| Shanghai East Hospital | OTHER |
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The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amygdala TI | Experimental | 5 sessions will be delivered in 3 weeks |
|
| Controlled TI | Sham Comparator | 5 sessions will be delivered in 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nervio-X | Device | An 8-channel TIS device developed by NEURODOME Corporation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Self-Report (16-item version) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (17-item version) | Baseline, 1 week, 4 weeks and 8 weeks | |
| Quick Inventory of Depressive Symptomatology - Self-Report (16-item version) | Baseline, 1 week and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yiru Fang, MD PhD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China | ||
| Shanghai East Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41871633 | Derived | Zhang C, Yang Y, Wang C, Wang L, Sun W, Mu C, Feng Z, Liu N, Guan X, Lu Y, Li S, Zhang C, Li J. Temporal interference stimulation (TIS) for major depressive disorder: right lingual gyrus as a predictor. J Affect Disord. 2026 Jul 15;405:121660. doi: 10.1016/j.jad.2026.121660. Epub 2026 Mar 21. |
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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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| Snaith-Hamilton Pleasure Scale | The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions. | Baseline, 1 week, 4 weeks and 8 weeks |
| Hamilton Anxiety Rating Scale | Baseline, 4 weeks and 8 weeks |
| Pittsburgh Sleep Quality Index | Baseline, 4 weeks and 8 weeks |
| 36-Item Short Form Health Survey | Baseline and 8 weeks |
| World Health Organization Quality of Life Assessment - Brief Version | Baseline and 8 weeks |
| Shanghai |
| China |
| Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University) | Tianjin | China |