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

NCT07021508 | Recruiting

• 1 other identifier: IIT20250009C-R1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale（MADRS）

  Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. MADRS has a minimum value of 0 and a maximum value of 60, with larger scores representing poorer results.

  * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"

Secondary Outcomes (9)

• Hamilton Depression Scale（HAMD-17)

  * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"

• Hamilton Anxiety Scale（HAMA）

  * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"

• Young Mania Rating Scale（YMRS）

  * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"

• Snaith-Hamilton Pleasure Scale（SHAPS）

  * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"

• Temporal Experience of Pleasure Scale (TEPS)

  * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"

Study Arms (2)

Temporal Interference Stimulation

ACTIVE COMPARATOR

Device: Temporal Interference Stimulation

Sham Temporal Interference Stimulation

SHAM COMPARATOR

Device: Sham Temporal Interference Stimulation

Interventions

Temporal Interference Stimulation 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.

Temporal Interference Stimulation

Sham Temporal Interference Stimulation 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.

Sham Temporal Interference Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Shaohua Hu, PhD

CONTACT

086-13957162903; dorhushaohua@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 15, 2025
• Study Start: May 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-02

Locations

CN (1)