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Life sciences · Interventional Study
ClinicalTrials.gov · September 21, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07829575). This is a study registration, not published results. Lead sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD. Interventions: DEVICE: Transcranial Temporal Interference Stimulation; DEVICE: Sham Transcranial Temporal Interference Stimulation. Primary outcome measures: Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score , Baseline; after 10 stimulation sessions (30 minutes per session; end of Week 2). Brief summary: This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of amygdala-targeted transcranial temporal interference stimulation (tTIS) in adults with major depressive disorder (MDD) and to explore its potential neurobiological mechanisms. The main questions this study aims to answer are: Whether active amygdala-targeted tTIS reduces depressive symptoms compared with sham stimulation. Whether tTIS produces changes in amygdala-related neural activity and functional brain networks that are associated with clinical improvement. Participants will be randomly assigned to receive either active tTIS or sham stimulation. They will complete a course of stimulation sessions and undergo clinical assessments before and after the intervention. Neuroimaging assessments will also be performed to investigate treatment-related changes in the amygdala and associated brain networks.