BCIwiki (bciwiki.com) — A multicenter clinical trial of closed-loop brain-computer interface neuromodulation for treatment-resistant depression has been launched in China, conducted at Shanghai Mental Health Center, Beijing Anding Hospital, and Xuanwu Hospital. The trial was first posted on the U.S. ClinicalTrials.gov registry on August 25, 2026, with identifier NCT07783906.
The study aims to evaluate the efficacy and safety of two neuromodulation approaches: closed-loop deep brain stimulation (DBS) and transcutaneous auricular vagus nerve stimulation (taVNS), compared with sham stimulation. Treatment-resistant depression refers to depression that does not improve sufficiently after adequate standard antidepressant therapy; the study targets patients with early-onset depression, a history of self-harm or suicidal ideation, or depression associated with traumatic experiences.
Using a multicenter, prospective design, eligible participants will choose either DBS or taVNS based on preference, and within each intervention group will be randomly assigned to active or sham stimulation. Follow-up assessments include depressive and anxiety symptoms, cognitive function, social functioning, EEG, MRI, and adverse event monitoring. The trial is not yet recruiting.