Efficacy and Safety of Task-specific, Biomarker-driven, High-definition, Closed-loop Transcranial Alternating Current Stimulation (HD-ctACS) in Treatment-Resistant Depression (TRD): A Randomized, Double-blind, Sham-controlled, Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from Baseline in Hamilton Depression Rating Scale 17-item (HAMD-17) Score
研究概览
简要总结
This is a single-center, randomized, double-blind, sham-controlled, crossover exploratory clinical trial designed to evaluate the therapeutic effects of task-specific, biomarker-driven HD-ctACS on treatment-resistant depression (TRD). The study will enroll 10 patients diagnosed with TRD. Each participant will, in a randomized order, undergo a 4-week active HD-ctACS treatment period and a 4-week sham stimulation (delayed HD-ctACS) period, separated by an 8-week washout period. The primary objective is to assess the efficacy of HD-ctACS in improving core depressive symptoms, with the primary outcome being the difference in the Hamilton Depression Rating Scale (HAMD) total score between the end of the two intervention periods. Secondary objectives include evaluating the safety of the therapy, its effects on other symptom dimensions, and exploring its modulatory effects on neurobiological markers of emotional processing (e.g., NAc gamma power). The total participation time for each subject is approximately 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years, any gender.
- •Meets DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), currently in a moderate to severe episode (total HAMD score ≥ 17).
- •Meets the definition of Treatment-Resistant Depression (TRD): failure to respond to or intolerance of at least two antidepressant medications from different mechanistic classes, administered at an adequate dose and duration (e.g., 6-8 weeks) during the current depressive episode.
- •Agrees to maintain a stable dosage of their current antidepressant medication regimen (if taking any) throughout the study period.
- •Able to comprehend the study procedures and voluntarily provide written informed consent.
- •Has intracranial deep brain electrodes implanted for research purposes, with electrodes located in the target brain regions (e.g., NAc, BNST).
排除标准
- •History of other severe psychiatric disorders such as schizophrenia or bipolar disorder.
- •Current severe suicide risk.
- •History of alcohol or substance abuse/dependence (within the last year).
- •History of epilepsy or has intracranial metal implants (other than the research electrodes).
- •Presence of any unstable and significant somatic illness.
- •Women who are pregnant or breastfeeding.
- •Currently participating in another clinical trial.
研究组 & 干预措施
sham stimulation and crossover to active stimulation
干预措施: HD ctACS (Device)
sham stimulation and crossover to active stimulation
干预措施: HD ctACS sham (Device)
active stimulation and crossover to sham stimulation
干预措施: HD ctACS (Device)
active stimulation and crossover to sham stimulation
干预措施: HD ctACS sham (Device)
结局指标
主要结局
Change from Baseline in Hamilton Depression Rating Scale 17-item (HAMD-17) Score
时间窗: Baseline, Week 2, and Week 4 (End of Intervention).
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated scale used to assess the severity of depression. The total score ranges from 0 to 52. A higher score indicates a worse outcome (i.e., greater depression severity).
次要结局
- Change from Baseline in Nucleus Accumbens (NAc) Gamma Power(Baseline, day1, day2, day3 day4, day5, day6, day7, day8, day9, day10, day11, day12, day13, day14, day15.)
- Amplitude of Event-Related Potential (ERP) in Response to Facial Stimuli(Baseline, day1, day2, day3 day4, day5, day6, day7, day8, day9, day10, day11, day12, day13, day14, day15.)