The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function.
The main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS.
Researchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment.
Participants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.
Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists
24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline
Aged 18 to 65 years
Right-handed
History of epilepsy, brain tumor, or brain trauma
Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months
Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging
Acute or severe suicidal ideation
Parallel
Active Transcranial Temporal Interference Stimulation Targeting Left ALIC
DeviceParticipants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Active Transcranial Temporal Interference Stimulation Targeting Left sgACC
DeviceParticipants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Sham Transcranial Temporal Interference Stimulation
DeviceParticipants in this arm will receive sham transcranial temporal interference stimulation (tTIS) using the same type of device as active stimulation. Sham stimulation will provide sensory feedback similar to active stimulation to help maintain masking, but it will not deliver the same active treatment dose. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess the severity of depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. The primary outcome is the change in HAMD-24 total score from baseline to Week 1.
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 2
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. This outcome measures the change in HAMD-24 total score from baseline to Week 2.
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 6
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. This outcome measures the change in HAMD-24 total score from baseline to Week 6.
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 1.
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 2.
Change in Brain Structural Imaging Metrics From 5.0T Magnetic Resonance Imaging
Brain structural imaging metrics will be derived from 5.0T structural magnetic resonance imaging. This outcome explores changes in brain structural imaging metrics from baseline to post-treatment.
Change in Resting-state Functional Connectivity From 5.0T Functional Magnetic Resonance Imaging
Resting-state functional connectivity will be derived from 5.0T resting-state functional magnetic resonance imaging. This outcome explores changes in resting-state functional connectivity from baseline to post-treatment.
Change in Diffusion Imaging Metrics From 5.0T Magnetic Resonance Imaging
Diffusion imaging metrics will be derived from 5.0T diffusion magnetic resonance imaging. This outcome explores changes in diffusion imaging metrics from baseline to post-treatment.
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Yonggui Yuan
Lead sponsor
Zhongda Hospital
Sponsor institution
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