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Starting soon Not applicable

The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression

NCT06826469 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-06
Last updated
2026-05-27

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

Temporal Interference Stimulation

Temporal Interference Stimulation: During the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is 3.64 mA+4.36 mA.

Study summary

This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18-50 years old, right-handed, and completed nine years of compulsory education; 2. Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression; 3. HAMD-17≥18; 4. Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks; 5. The subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI). Exclusion Criteria: 1. Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.; 2. Severe suicidal ideation or behavior; 3. History of a serious physical illness or a disease that may affect the central nervous system; 4. Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy; 5. Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies); 6. Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments; 7. Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.

Primary outcome measure(s)

  • Hamilton Depression Scale(HAMD-17) — 0-5 days
    The Hamilton Depression Scale(HAMD-17) was used to assess the extent of the patient's depressive episodes, with higher scores representing more severe depression, and this scale was used to monitor the patient's improvement in depression before and after treatment.

Trial sites (1)

FacilityCityRegionStatus
Department of Psychiatry, First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06826469 on ClinicalTrials.gov ↗ ← All trials in China