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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.
Xijing Hospital
Xian, Shanxi, China
RECRUITINGHAMD-17
HAMD-17 score reduction rate at 6 months of follow-up compared to baseline
Time frame: 6 months
HAMD-17
HAMD-17 score reduction rate at 3,12 months of follow-up compared to baseline
Time frame: 12months
MADRS
Changes in MADRS scores at 3, 6, and 12 months of follow-up compared to baseline
Time frame: 12months
IDS-SR
Changes in IDS-SR scores at 3, 6, and 12 months of follow-up compared to baseline
Time frame: 12months
CGI
Changes in CGI scores at 3, 6, and 12 months of follow-up compared to baseline
Time frame: 12months
PSQI
Changes in PSQI scores at 3, 6, and 12 months of follow-up compared to baseline
Time frame: 12months
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