Life sciences · Interventional Study
ClinicalTrials.gov · October 22, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07888387). This is a study registration, not published results. Lead sponsor: Ruijin Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 15 participants (ACTUAL). Conditions: Major Depressive Disorder (MDD). Interventions: DEVICE: Temporal Interference Stimulation; DEVICE: Temporal Interference Stimulation; DEVICE: Temporal Interference Stimulation; DEVICE: Temporal Interference Stimulation; DEVICE: Temporal Interference Stimulation. Primary outcome measures: Number of Participants Who Completed All Five Stimulation Sessions , Up to 5 weeks; Number of Participants With Adverse Events , Up to 5 weeks; Participant-Reported Discomfort During Stimulation , Immediately after each of the five weekly sessions (Weeks 1-5); Change in resting-state functional connectivity , Immediately before and after each stimulation session. Brief summary: This pilot feasibility study used a randomized, double-blind, within-subject crossover design to explore temporal interference (TI) stimulation in adults with major depressive disorder. Fifteen participants received five weekly 20-minute stimulation sessions in randomized order, including TI stimulation targeting the left dorsolateral prefrontal cortex, left subgenual anterior cingulate cortex, right amygdala, and right ventral striatum, as well as a sham stimulation condition. The primary aim was to establish the feasibility of target-specific TI stimulation and to characterize its effects on functional connectivity and cognitive-emotional processing, assessed by resting-state fMRI and an emotional Stroop task before and after each session. Depressive and anxiety symptoms (HAMD and HAMA) were collected longitudinally across the five-week protocol as a secondary, exploratory measure.