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Amygdala-Targeted Transcranial Temporal Interference Stimulation for Major Depressive Disorder: A Randomized Sham-Controlled Trial of Clinical Efficacy and Neurobiological Mechanisms
Sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
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.
Official title: Amygdala-targeted Temporal Interference Stimulation for Major Depressive Disorder。
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10-20
Completion Date
2027-12-30
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Transcranial Temporal Interference Stimulation
Active transcranial temporal interference stimulation (tTIS) will be delivered using two pairs of scalp electrodes. Two high-frequency alternating currents with slightly different carrier frequencies will be applied to generate a low-frequency temporal interference envelope within the targeted amygdala region. Electrode placement and stimulation parameters will be determined according to the study protocol and individualized electric-field modeling when applicable. Participants assigned to the active group will receive 10 stimulation sessions, with each session lasting 30 minutes, according to the predefined treatment schedule.
Sham Transcranial Temporal Interference Stimulation
Participants assigned to the sham group will undergo the same electrode placement and treatment procedures as the active stimulation group. Sham stimulation will include brief ramp-up and ramp-down periods to mimic the initial sensory experience of active stimulation, without delivering continuous therapeutic stimulation during the remainder of the session.
Locations (1)
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, China