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Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials
This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vagus nerve stimulation | Device | Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator. |
| Measure | Description | Time Frame |
|---|---|---|
| HAMD-17 | HAMD-17 score reduction rate at 6 months of follow-up compared to baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HAMD-17 | HAMD-17 score reduction rate at 3,12 months of follow-up compared to baseline | 12months |
| MADRS | Changes in MADRS scores at 3, 6, and 12 months of follow-up compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| safety | The incidence of adverse events and serious adverse events at each visit | 12months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Huaning | Contact | 13609161341 | xskzhu@fmmu.edu.cn | |
| Chen Yihuan | Contact | chenyh47@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xian | Shanxi | China |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| 12months |
| IDS-SR | Changes in IDS-SR scores at 3, 6, and 12 months of follow-up compared to baseline | 12months |
| CGI | Changes in CGI scores at 3, 6, and 12 months of follow-up compared to baseline | 12months |
| PSQI | Changes in PSQI scores at 3, 6, and 12 months of follow-up compared to baseline | 12months |