An interventional study of Temporal Interference Stimulation and Temporal Interference Stimulation in Major Depressive Disorder (MDD), sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Other
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.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 15 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
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Temporal interference stimulation targeting the left dorsolateral prefrontal cortex (DLPFC), using a 10-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods.
Device: Temporal Interference Stimulation
Temporal interference stimulation targeting the left subgenual anterior cingulate cortex (sgACC), using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods.
Device: Temporal Interference Stimulation
Temporal interference stimulation targeting the right amygdala, using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods.
Device: Temporal Interference Stimulation
Temporal interference stimulation targeting the right ventral striatum, using a 100-Hz difference frequency. Stimulation intensity started at 1 mA and was increased in 0.2-mA increments according to tolerability, up to a maximum of 4 mA. Stimulation was delivered for 20 minutes with 2-second ramp-up and ramp-down periods.
Device: Temporal Interference Stimulation
For sham stimulation, two currents at the same 2-kHz frequency were applied using an electrode configuration randomly selected from one of the four active target montages, producing a 0-Hz difference frequency. Current was delivered so that participants could not distinguish sham from active stimulation. Stimulation lasted 20 minutes.
Device: Temporal Interference Stimulation
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Temporal interference (TI) stimulation is a non-invasive neuromodulation technique that uses two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope at the difference frequency, enabling modulation of neural activity.
Number of Participants Who Completed All Five Stimulation Sessions
Feasibility, defined as the number of enrolled participants who completed all five weekly 20-minute stimulation sessions. Reported descriptively; no formal hypothesis test.
Time frame: Up to 5 weeks
Number of Participants With Adverse Events
Tolerability, defined as the number of participants experiencing at least one adverse event during or after any of the five stimulation sessions, summarized by severity (mild, moderate, severe). Reported descriptively; no formal hypothesis test.
Time frame: Up to 5 weeks
Participant-Reported Discomfort During Stimulation
Discomfort during each 20-minute session, record the number of participants reporting any discomfort. Reported descriptively; no formal hypothesis test.
Time frame: Immediately after each of the five weekly sessions (Weeks 1-5)
Change in resting-state functional connectivity
Seed-based resting-state functional connectivity computed from fMRI acquired immediately before and after each session. For each target, FC is the Fisher z-transformed temporal correlation between the seed time series and other voxels. Outcome is the pre-to-post change (post minus pre) under active stimulation versus sham, at group level.
Time frame: Immediately before and after each stimulation session
Change in depressive symptoms (HAMD)
Depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17). Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms (worse outcome). Outcome is the change in total score from baseline, analyzed as a secondary, exploratory measure. Study not powered for target-specific or antidepressant effects.
Time frame: Baseline (before the first session), Weeks 2, 3, 4,5,7
Change in anxiety symptoms (HAMA)
Anxiety symptom severity measured by the 14-item Hamilton Anxiety Rating Scale (HAMA). Total score ranges from 0 to 56; higher scores indicate more severe anxiety symptoms (worse outcome). Outcome is the change in total score from baseline, analyzed as a secondary, exploratory measure.
Time frame: Baseline, Weeks 2, 3, 4, 5, and 7
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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