NCT04153812

Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Refractory Depression

Interventions

Type	Name	Description
DEVICE	vagus nerve stimulation	Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-10-01
• Completion: 2022-05-30
• First posted: 2019-11-06
• Last updated: 2019-11-06

Locations

1 site across 1 country: China