Efficacy and Safety of Task-State-Based Temporal Interference Stimulation (TI) in Improving Depression in Patients With Bipolar Disorder

First Affiliated Hospital of Zhejiang University1 site in 1 country36 target enrollmentJuly 16, 2024

ConditionsBipolar Depression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bipolar Depression
Sponsor: First Affiliated Hospital of Zhejiang University
Enrollment: 36
Locations: 1
Primary Endpoint: Hamilton Depression Scale（HAMD-17)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2024

End Date

September 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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.