Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression

NCT ID: NCT07021508

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2026-05-31

Brief Summary

The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.

Conditions

Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Temporal Interference Stimulation

Group Type: ACTIVE_COMPARATOR

Temporal Interference Stimulation

Intervention Type: DEVICE

A non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity.

Sham Temporal Interference Stimulation

Group Type: SHAM_COMPARATOR

Sham Temporal Interference Stimulation

Intervention Type: DEVICE

The same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation.

Interventions

Temporal Interference Stimulation

A non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity.

Intervention Type: DEVICE

Sham Temporal Interference Stimulation

The same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• right-handed, and have completed nine years of compulsory education;
• Meet the diagnostic criteria for bipolar depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
• ≥18 points on the Hamilton Depression Inventory (HAMD- 17);
• ≤8 points on the Young's Mania Rating Scale (YMRS);
• Subjects who have not been treated with psychiatric medication, or those who have been treated with medication are required to undergo medication washout within 2 weeks before randomization;
• Subjects/legal guardians are willing to cooperate with the treatment and sign an informed consent form after they have fully understood the Temporal Interference Stimulation (TI).

Exclusion Criteria

• Contraindications to magnetic resonance scanning (MRI) 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);
• Prior or current electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), transcranial direct current therapy (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation;
• Pregnant and lactating women, and women of childbearing age with a positive urine pregnancy;
• Possesses a diagnosis of another major psychiatric disorder that has been assessed by the study investigator as a major disorder that results in more impairment than a diagnosis of bipolar disorder;
• Co-morbid other psychiatric disorders, including obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.; Has active suicidal ideation (≥ 4 points on item 10 of the MADRS);
• Risk of serious injury to self or others;
• History of serious physical illness or disease that may affect the central nervous system;
• Risk of neurologic disorders or seizures, such as previous craniosynostosis, cranial trauma, abnormal electroencephalograms, magnetic resonance evidence of structural abnormalities of the brain, or family history of epilepsy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaohua Hu, PhD

Role: CONTACT

dorhushaohua@zju.edu.cn

086-13957162903

Facility Contacts

Hu ShaoHua, MD

Role: primary

dorhushaohua@zju.edu.cn

13957162903

Other Identifiers

IIT20250009C-R1

Identifier Type: -

Identifier Source: org_study_id