A Multicenter Randomized Double-Blind Controlled Trial of Six-Week Transcranial Temporal Interference Stimulation（TIS） Targeting the Right Amygdala for Rapid Alleviation of Depressive Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Hamilton Depression Rating Scale (17-item version)
研究概览
简要总结
The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 18 to 60 years (inclusive), any gender.
- •Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes.
- •Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening.
- •Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using >2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents* ≥1 week prior to enrollment.
- •Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments.
- •Compliance : Investigator-confirmed understanding of study objectives/procedures, protocol compliance, and provision of written informed consent.
排除标准
- •Comorbidities : Major psychiatric disorders (e.g., schizophrenia, bipolar disorder) Significant neurological conditions (e.g., traumatic brain injury, post-neurosurgical status)
- •Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems)
- •Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment
- •Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment
- •Concurrent Trials : Participation in other interventional clinical studies during the trial period
- •Reproductive Status : Pregnancy, lactation, or plans for conception during the trial
- •Suicide Risk : Score ≥3 on Item 3 of the 17-item Hamilton Depression Rating Scale (HAMD-17)
- •Any condition deemed to compromise subject safety or study validity per clinical evaluation
研究组 & 干预措施
Amygdala TI
18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks
干预措施: Nervio-X (Device)
Controlled TI
18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks
干预措施: Nervio-X (Device)
结局指标
主要结局
Hamilton Depression Rating Scale (17-item version)
时间窗: Baseline, 6 weeks
The Hamilton Depression Rating Scale is a widely utilized clinician-administered instrument for assessing depression severity, consisting of 17 items that evaluate core depressive symptoms. Total scores range from 0-52, with established cutoff points: 0-7 (no depression/remission), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (severe depression), and ≥23 (very severe depression). The HAM-D17 demonstrates good internal consistency reliability with Cronbach's alpha values ranging from 0.747 to 0.829.
次要结局
- Hamilton Depression Rating Scale (17-item version)(Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks)
- THINC-it®: An Integrated Tool for Cognitive Dysfunction Screening(Baseline, 2 weeks, 6 weeks, 10 weeks)
- Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks)
- Hamilton Anxiety Rating Scale (HAMA)(Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 2 weeks, 6 weeks, 10 weeks)
- 36-Item Short Form Health Survey (SF-36)(Baseline and 10 weeks)
- World Health Organization Quality of Life Assessment - Brief Version (WHOQOL-BREF)(Baseline and 10 weeks)
- Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)(Baseline, 1 week, 2 weeks, 6weeks, 10 weeks)
研究者
ZHANG CHENCHEHG
Clinical Neuroscience Center Deputy Director
Ruijin Hospital