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

NCT06516991 | Completed

• 1 other identifier: IIT20220008C-R2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale（HAMD-17)

  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 Outcomes (5)

• Montgomery-Asberg Depression Rating Scale（MADRS）

  0-5 days

• Hamilton Anxiety Scale（HAMA）

  0-5 days

• Young Mania Rating Scale（YMRS）

  0-5 days

• Snaith-Hamilton Pleasure Scale（SHAPS）

  0-5 days

• Temporal Experience of Pleasure Scale (TEPS)

  0-5 days

Study Arms (1)

Temporal Interference Stimulation

EXPERIMENTAL

Temporal Interference Stimulation

Device: Temporal Interference Stimulation

Interventions

Temporal Interference Stimulation DEVICE

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. 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.

Temporal Interference Stimulation

Eligibility Criteria

• Age: 16 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 16-50 years, right-handed, and completed nine years of compulsory education;
• Meet the diagnostic criteria for bipolar disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
• HAMD-17: \>17 points , assessed the presence of rapture deficits;
• Subject had not been treated with a mood stabilizer, or had previously used an antidepressants and currently off medication for ≥1 week;
• The subject/legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after being fully informed of the temporal interference stimulus (TI).

You may not qualify if:

• Co-morbid other psychiatric disorders, including affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
• History of a serious physical illness or a disease that may affect the central nervous system;
• 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;
• 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);
• 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;
• Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 16, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)