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

May 25, 2026 updated by: First Affiliated Hospital of Zhejiang University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temporal Interference Stimulation
Specific electrode sites are customized for the subject through magnetic resonance scanning, the deep nucleus cluster to be stimulated-nucleus accumbens is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale（HAMD-17)
Time Frame: 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.
0-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale（MADRS）
Time Frame: 0-5 days
The Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effectiveness of antidepressant treatment and to monitor changes in a patient's condition. The scale is a stand-alone scale whose ratings are based on a clinical interview with questioning about symptoms that leads to a rating of depression severity.
0-5 days
Beck Scale for Suicide Ideation (BSS)
Time Frame: 0-5 days
The Beck Suicidal Ideation Scale was used to assess the patients' suicidal ideation.
0-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20240117C-R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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