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

Zhejiang University

Status

Completed

Conditions

Bipolar Depression

Treatments

Device: Temporal Interference Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06516991

IIT20220008C-R2

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

16 to 38 years old

Volunteers

No Healthy Volunteers

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.