The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale（HAMD-17)
研究概览
简要总结
This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-50 years old, right-handed, and completed nine years of compulsory education;
- •Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;
- •HAMD-17≥18;
- •Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;
- •The subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI).
排除标准
- •Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
- •Severe suicidal ideation or behavior;
- •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.
研究组 & 干预措施
Temporal Interference Stimulation
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.
干预措施: Temporal Interference Stimulation (Device)
结局指标
主要结局
Hamilton Depression Scale（HAMD-17)
时间窗: 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.
次要结局
- Montgomery-Asberg Depression Rating Scale（MADRS）(0-5 days)
- Beck Scale for Suicide Ideation (BSS)(0-5 days)