The Study on Effectiveness and Mechanisms of Transcranial Alternating Current Stimulation in Treating Increased Inflammatory Activity Refractory Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- the change in scores of HAMD-17 after treatment
研究概览
简要总结
This study is a randomized controlled trial with a duration of 12 weeks (4 weeks of intervention + 8 weeks of follow-up). The participants are patients with treatment-resistant depression (TRD) and high inflammatory activity (n=52). The study aims to clarify the effectiveness of 15mA, 77.5Hz transcranial alternating current stimulation (tACS) in treating TRD with high inflammatory activity by comparing the changes in depressive symptoms and biological markers after active tACS stimulation versus sham stimulation. Additionally, the study seeks to explore potential underlying mechanisms of action.
详细描述
This experiment is a randomized controlled trial lasting 12 weeks (4 weeks of intervention + 8 weeks of follow-up), with participants being patients with treatment-resistant depression (TRD) and high inflammatory activity (n=52). The study aThis study plans to include 52 patients with treatment-resistant depression (TRD) and high inflammatory activity who meet the inclusion and exclusion criteria. Participants will be randomly assigned to either the active stimulation group (active group, n=26) or the sham stimulation group (sham group, n=26). During the baseline phase, basic information (e.g., gender, age, age of onset, family history of mental illness) will be collected, and assessments using scales (as detailed in the experimental methods) will be completed. EDTA blood collection tubes will be used to collect 10ml of fasting peripheral venous blood (-80°C for storage). The intervention will begin the following day with either tACS or sham stimulation.
Before the first tACS or sham treatment, participants will undergo resting-state electroencephalogram (EEG) recordings to assess brain wave activity in different brain regions. Participants will receive a total of 20 sessions of tACS or sham intervention (5 sessions per week, with a break on weekends). At the end of weeks 2 and 4, the scales will be reassessed. After the 4-week intervention period ends, another EEG will be recorded, and fasting peripheral venous blood (10ml) will be collected the following morning for storage.
After the intervention phase, participants will enter an 8-week follow-up period. At the 8th and 12th weeks, all participants will undergo a reassessment using the HAMD-17 scale and provide 10ml of peripheral venous blood for analysis. The data from the scales, blood analysis, and EEG will be summarized and used for statistical analysis. Throughout the study, participants' antidepressant medication will remain unchanged.
The specific details are as follows:
- Assessment of Treatment Efficacy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Aged between 18 and 55 years; (2) Diagnosed with depression through a structured clinical interview by a psychiatrist using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) A total score of 17 or above on the 17-item Hamilton Depression Rating Scale (HAMD-17), with a score of 2 or more on item 1 (depression); (4) CRP level between 0.85-10 mg/L; (5) DM-TRD score of at least 12.5; (6) Stable use of treatment medications (antidepressants, antipsychotics) for at least 2 weeks during the current depressive episode; (7) Able to understand and sign the informed consent form.
排除标准
- •(1) A history of current or past seizures, epilepsy, hydrocephalus, central nervous system tumors, or acute brain injury and infections; (2) A score of 3 or 4 on item 3 of the HAMD-17, or a history of suicidal behavior with significant suicide risk; (3) Received electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neuromodulation treatments within one month prior to enrollment; (4) Pregnant or breastfeeding women; (5) Patients with any severe organic disease or in an unstable condition due to organic disease; (6) Used anti-inflammatory drugs for more than 7 days cumulatively in the last 2 months, or used immunosuppressive drugs, such as corticosteroids; (7) Suffering from chronic infectious or autoimmune diseases, such as lupus, enteritis, hepatitis, etc.; (8) A history of substance dependence or substance abuse.
结局指标
主要结局
the change in scores of HAMD-17 after treatment
时间窗: 4 weeks (at the end week 4)
次要结局
- the change in scores of HAMD-17 after follow up(12 weeks (at the end week 12))
- the change in levels of serum biomarkers after treatment and follow up(4 and 12 weeks (at the end week 4 and 12))
- the change in power of EEG activity in specific brain regions after treatment and follow up(4 and 12 weeks (at the end week 4 and 12))
研究者
Jie Li
professor
Tianjin Anding Hospital