An interventional study of Single-target active temporally interfering electrical stimulation and Dual-target active temporally interfering electrical stimulation in Major Depressive Disorder (MDD), sponsored by Tianjin Medical University General Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Tianjin Medical University General Hospital · Not applicable, Interventional, and Treatment
Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution. Although its effects on human brain function and behavior have been increasingly investigated, its clinical utility in major depressive disorder (MDD) has not been established. This trial aims to evaluate the efficacy and safety of TI electrical stimulation in MDD patients.
This is a multicenter, double-blind, randomized, sham-controlled trial including three parallel arms: (1)single-target active stimulation targeting the right primary auditory cortex (A1); (2) dual-target active stimulation targeting the right A1 and the right dorsolateral prefrontal cortex (DLPFC); (3)sham stimulation. All interventions will be delivered over two consecutive weeks, comprising ten treatment visits, with 20 minutes of stimulation applied to each target.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 75 is close to the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Single-target active temporally interfering electrical stimulation
Device: Dual-target active temporally interfering electrical stimulation
Device: Sham temporally interfering electrical stimulation
Single-target active stimulation targeting the right primary auditory cortex (A1), each target stimulation phase will last 20 minutes, including a 30-second ramp-up at onset and a 30-second ramp-down at termination. Alternating currents with frequencies of f1 = 2000 Hz and f2 = 2040 Hz will be delivered through the two electrode pairs, and the total current intensity across the two electrode pairs will be fixed at 4 mA (AC, peak-to-base). The intervention will be administered over two consecutive weeks, with participants receiving stimulation on five days per week.
Dual-target active stimulation targeting the right A1 and the right dorsolateral prefrontal cortex (DLPFC), each target stimulation phase will last 20 minutes, including a 30-second ramp-up at onset and a 30-second ramp-down at termination. For each target, two pairs of electrodes will be used; the alternating current frequency and total stimulation intensity will be the same as those in the single-target active TI electrical stimulation group.The intervention will be administered over two consecutive weeks, with participants receiving stimulation on five days per week.
Sham TI electrical stimulation group will follow the same session duration, treatment frequency, and procedural setup as the active stimulation groups. However, electrical stimulation will be limited to an initial 30-second ramp-up followed immediately by a 30-second ramp-down, after which no current will be delivered for the remainder of the session.
Hamilton Depression Rating Scale 17-item (HAMD-17)
Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Patient Health Questionnaire-9 (PHQ-9)
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Hamilton Anxiety Rating Scale (HAMA)
Total scores range from 0 to 56, with higher scores indicating greater anxiety symptom severity (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Generalized Anxiety Disorder 7-item (GAD-7)
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Young Mania Rating Scale (YMRS)
Total scores range from 0 to 60, with higher scores indicating greater manic symptom severity (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Electroencephalographic (EEG) Power in the Gamma Frequency Band
Gamma-band EEG power will be assessed using spectral analysis of EEG recordings.
Time frame: Baseline, Week 1, Week 2, Week 4.
40-Hz Auditory Steady-State Response (ASSR) Event-Related Spectral Perturbation (ERSP)
The 40-Hz ASSR will be assessed using electroencephalography (EEG). Event-related spectral perturbation (ERSP) quantifies stimulus-induced changes in oscillatory power relative to a prestimulus baseline. ERSP will be expressed in decibels (dB), with higher values indicating greater stimulus-related power enhancement.
Time frame: Baseline, Week 1, Week 2, Week 4.
40-Hz Auditory Steady-State Response (ASSR) Inter-Trial Coherence (ITC)
The 40-Hz ASSR will be assessed using electroencephalography (EEG). Inter-trial coherence (ITC) quantifies the consistency of oscillatory phase across repeated auditory stimulus presentations. ITC values range from 0 to 1, with higher values indicating greater phase consistency.
Time frame: Baseline, Week 1, Week 2, Week 4.
Magnetic Resonance Imaging (MRI)
Changes in brain structure and functional organization, assessed using MRI, will be included as secondary neuroimaging outcomes.
Time frame: Baseline, Week 2.
Athens Insomnia Scale (AIS)
Total scores range from 0 to 24, with higher scores indicating greater insomnia symptom severity (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Attention Control Scale (ACS)
The ACS consists of 20 items assessing two dimensions of attentional control: Attentional Focusing and Attentional Shifting. Total scores range from 20 to 80, with higher scores indicating better overall attentional control abilities (better outcomes). Attentional Focusing reflects the ability to maintain attention and resist distractions, whereas Attentional Shifting reflects the ability to flexibly shift attention between tasks or stimuli.
Time frame: Baseline, Week 1, Week 2, Week 4.
Chinese 10-item Rumination Response Scale (RRS-10)
The RRS-10 consists of 10 items assessing two dimensions of rumination: Brooding and Reflection, each comprising five items. Total scores range from 10 to 40, with higher scores indicating greater overall rumination (generally worse outcomes). Brooding reflects maladaptive rumination, whereas Reflection reflects purposeful self-focused thinking and does not necessarily indicate worse outcomes.
Time frame: Baseline, Week 1, Week 2, Week 4.
Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal Subscale
The Cognitive Reappraisal subscale of the ERQ consists of 6 items assessing the tendency to regulate emotions by reinterpreting emotional situations. Total scores range from 6 to 42, with higher scores indicating greater use of cognitive reappraisal, generally considered a more adaptive emotion regulation strategy (better outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Emotion Regulation Questionnaire (ERQ) - Expressive Suppression Subscale
The Expressive Suppression subscale of the ERQ consists of 4 items assessing the tendency to inhibit outward emotional expression. Total scores range from 4 to 28, with higher scores indicating greater use of expressive suppression, generally considered a less adaptive emotion regulation strategy (worse outcomes).
Time frame: Baseline, Week 1, Week 2, Week 4.
Cognitive Flexibility Inventory (CFI)
The CFI consists of 20 items assessing two dimensions of cognitive flexibility: Alternatives (13 items) and Control (7 items). Total scores range from 20 to 100, with higher scores indicating greater cognitive flexibility (better outcomes). Alternatives reflects the ability to generate multiple explanations and solutions to difficult situations, whereas Control reflects the tendency to perceive difficult situations as controllable.
Time frame: Baseline, Week 1, Week 2, Week 4.
Plan to share: No
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Tianjin Medical University General Hospital