Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder
A Double-Blind, Randomized, Sham-Controlled Clinical Trial of Temporal Interference Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD)
Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala.
The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months.
The primary outcome for MDD is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles.
研究概览
地位
条件
详细说明
Major depressive disorder (MDD) is a highly prevalent psychiatric disorder associated with substantial disability and impaired quality of life. Neuroimaging studies have demonstrated abnormalities in distributed cortical-subcortical circuits, particularly involving the amygdala, which plays a central role in emotional processing and symptom regulation. Although several neuromodulation techniques have shown therapeutic potential, currently available approaches have limited ability to selectively modulate deep brain structures without invasive procedures.
Temporal interference transcranial alternating current stimulation (TI-tACS) is a novel non-invasive neuromodulation technique that delivers two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope within deep brain regions. This approach enables selective modulation of deep neural structures, such as the amygdala, while minimizing stimulation of the overlying cortex.
This is a multicenter, randomized, triple-blind, sham-controlled clinical trial designed to evaluate the efficacy, safety, and neurobiological mechanisms of TI-tACS in participants with MDD. Participants will be enrolled randomized to receive active or sham TI-tACS according to the study protocol.
Approximately 102 participants will be recruited. Following written informed consent, participants will undergo baseline assessments and subsequent study evaluations according to the protocol. Study assessments include clinical evaluations, neurocognitive testing, electroencephalography (EEG), magnetic resonance imaging (MRI), and biological sample collection. TI-tACS treatment consists of 20 stimulation sessions administered over two weeks (two sessions per day for five consecutive days, followed by a two-day break, and another five consecutive treatment days).
Participants will also complete scheduled post-treatment follow-up assessments to evaluate the persistence of treatment effects and the long-term safety of TI-tACS.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yumeng Ju( Associate Researcher), PhD
- 电话号码：86+18100731091
- 邮箱：yumeng.ju@csu.edu.cn
研究联系人备份
- 姓名：Lingsi Zeng, PhD Candidate
- 邮箱：zenglsi@163.com
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Age between 18 and 55 years (inclusive), any gender;
- Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;
- HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose;
- Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;
- Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures.
Exclusion Criteria:
- History of psychiatric disorders other than MDD;
- Pregnancy or lactation;
- Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);
- History of significant head injury or coma
- Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment
- Suspected or confirmed history of alcohol or substance dependence;
- Current severe suicidal ideation or recent suicide attempt;
- Current participation in another clinical trial or recent use of prohibited psychotropic medications;
- Positive urine drug screening or abnormal thyroid function tests;
- Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);
- Inability to provide fully informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：High-frequency TI-tACS
Participants in the High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (130Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency （130HZ or 2HZ) envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.
其他名称：
|
|
实验性的：Low-frequency TI-tACS
Participants in the Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (2 Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency （130HZ or 2HZ) envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.
其他名称：
|
|
假比较器：Sham TI-tACS
Participants in the Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2.
大体时间：2 weeks(from baseline)
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered instrument used to assess the severity of depressive symptoms.
The scale consists of 17 items with a total score ranging from 0 to 52.
Higher scores indicate more severe depressive symptoms.
The primary outcome for MDD participants will be calculated as the change in HAMD-17 score from baseline to Week 2.
|
2 weeks(from baseline)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
大体时间：Baseline to month 2 follow-up(post treatment)
|
A 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms.
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
|
Baseline to month 2 follow-up(post treatment)
|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
大体时间：Baseline to month 2 follow-up
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered instrument used to assess the severity of depressive symptoms and sensitivity to treatment-related changes.
The scale consists of 10 items with a total score ranging from 0 to 60. Higher scores indicate more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
|
Adverse Events Related to treatment
大体时间：Baseline to month 2 follow-up
|
Incidence, type, and severity of adverse events related to the transcranial temporal interference stimulation, assessed using a standardized Neuromodulation Adverse Effects Questionnaire.
|
Baseline to month 2 follow-up
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
大体时间：Baseline to month 2 follow-up
|
A 9-item self-report questionnaire used to assess depressive symptom severity.
Total scores range from 0 to 27, with higher scores indicating greater depression severity.
|
Baseline to month 2 follow-up
|
|
Change in the Hamilton Anxiety Rating Scale (HAMA) Score
大体时间：Baseline to month 2 follow-up
|
The Hamilton Depression Rating Scale-17 (HAMD-17) is a 17-item clinician-administered scale used to assess the severity of depressive symptoms.
The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
|
Change in Young Mania Rating Scale (YMRS) Score
大体时间：Baseline to month 2 follow-up
|
The Young Mania Rating Scale (YMRS) is an 11-item clinician-administered instrument used to assess the severity of manic symptoms and to monitor treatment-emergent mania or hypomania.
Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms.
|
Baseline to month 2 follow-up
|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Score
大体时间：Baseline to month 2 follow-up
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess subjective sleep quality and sleep disturbances over the previous month.
The questionnaire generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
|
Baseline to month 2 follow-up
|
|
Change in Beck Scale for Suicide Ideation (BSI) Score
大体时间：Baseline to month 2 follow-up
|
The Beck Scale for Suicide Ideation (BSI) is a 19-item clinician-administered instrument used to assess the severity of suicidal thoughts, attitudes, and intentions.
Total scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
|
Baseline to month 2 follow-up
|
|
hange in 10-item Connor-Davidson Resilience Scale (CD-RISC-10) Score
大体时间：Baseline to month 2 follow-up
|
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is a 10-item self-report questionnaire used to assess psychological resilience and the ability to cope with adversity.
Total scores range from 0 to 40, with higher scores indicating greater psychological resilience.
|
Baseline to month 2 follow-up
|
|
Change in Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) Score
大体时间：Baseline to month 2 follow-up
|
The Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) is a 36-item self-report questionnaire used to assess cognitive emotion regulation strategies in response to stressful or negative life events.
Total scores range from 36 to 180, with higher scores indicating greater use of cognitive emotion regulation strategies.
|
Baseline to month 2 follow-up
|
|
Change in State Anxiety Inventory (S-AI) Score
大体时间：Baseline to month 2 follow-up
|
The State Anxiety Inventory (S-AI) is a 20-item self-report questionnaire used to assess transient anxiety experienced at the time of assessment.
Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
|
Baseline to month 2 follow-up
|
|
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Score
大体时间：Baseline to month 2 follow-up
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-administered instrument used to assess the severity of depressive symptoms.
Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
|
Change in Sheehan Disability Scale (SDS) Score
大体时间：Baseline to month 2 follow-up
|
he Sheehan Disability Scale (SDS) is a 3-item self-report questionnaire used to assess functional impairment in work/school, social life, and family life/home responsibilities.
Total scores range from 0 to 30, with higher scores indicating greater functional impairment.
|
Baseline to month 2 follow-up
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
大体时间：Baseline to month 2 follow-up
|
The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report questionnaire used to assess anhedonia, or the ability to experience pleasure.
Total scores range from 14 to 56, with higher scores indicating greater anhedonia (reduced ability to experience pleasure).
|
Baseline to month 2 follow-up
|
|
Change in Ruminative Responses Scale (RRS) Score
大体时间：Baseline to month 2 follow-up
|
The Ruminative Responses Scale (RRS) is a 22-item self-report questionnaire used to assess the tendency to engage in repetitive negative thinking in response to depressed mood or distress.
Total scores range from 22 to 88, with higher scores indicating greater rumination.
|
Baseline to month 2 follow-up
|
合作者和调查者
合作者
调查人员
- 学习椅：Yan Zhang, PhD、Second Xiangya Hospital of Central South University
- 首席研究员：Yumeng Ju, PhD、Second Xiangya Hospital of Central South University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- LYG20240121
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.