Task-State-Based Temporal Interference Stimulation (TI) to Improve Depression in Patients With Bipolar Disorder

Last updated: April 3, 2025
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Completed

Phase

N/A

Condition

Depression (Treatment-resistant)

Depression

Bipolar Disorder

Treatment

Temporal Interference Stimulation

Clinical Study ID

NCT06516991
IIT20220008C-R2
  • Ages 16-38
  • All Genders

Study Summary

The purpose of this study is to investigate the efficacy and safety of temporal interference stimulation (TI) in improving depressive episodes of bipolar disorder, to analyze the therapeutic principle of TI in bipolar disorder depressive episodes based on task state MRI scanning, and to explore the abnormal regulation mechanism of anhedonia neural circuit.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 16-50 years, right-handed, and completed nine years of compulsory education;

  2. Meet the diagnostic criteria for bipolar disorder in the Diagnostic and StatisticalManual of Mental Disorders, Fifth Edition (DSM-5);

  3. HAMD-17: >17 points , assessed the presence of rapture deficits;

  4. Subject had not been treated with a mood stabilizer, or had previously used anantidepressants and currently off medication for ≥1 week;

  5. The subject/legal guardian is willing to actively cooperate with the treatment andsign an informed consent form after being fully informed of the temporalinterference stimulus (TI).

Exclusion

Exclusion Criteria:

  1. Co-morbid other psychiatric disorders, including affective psychiatric disorders,anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;

  2. History of a serious physical illness or a disease that may affect the centralnervous system;

  3. Neurologic disorders or risk of seizures such as previous cranial disorders, headtrauma, abnormal electroencephalograms, magnetic resonance evidence of structuralbrain abnormalities, or a family history of epilepsy;

  4. 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, andother metallic foreign bodies);

  5. Those who have received or are receiving electroconvulsive therapy (ECT ), modifiedelectroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS),transcranial direct current stimulation (tDCS), transcranial alternating currentstimulation (tACS), or other neurostimulation treatments;

  6. Pregnant and lactating women, and women of childbearing age with positive urinepregnancy.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Temporal Interference Stimulation
Phase:
Study Start date:
July 16, 2024
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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