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多靶点经颅直流电刺激治疗共病抑郁与慢性疼痛：一项多中心随机对照试验

2026年9月1日 更新者：Shanghai Mental Health Center

经颅电刺激治疗共病抑郁与疼痛：从技术发展到多中心临床试验转化

本临床试验旨在研究一种新型非药物干预方法——经颅直流电刺激（tDCS）用于治疗共病抑郁症和疼痛。 主要目标是通过多中心随机对照设计优化神经刺激参数，并阐明该共病潜在的神经回路-免疫相互作用机制。 患有共病抑郁症和慢性疼痛的参与者将被随机分配接受主动多靶点经颅电刺激或假刺激。 干预期将持续2周，随后进行一系列治疗后随访评估。 研究人员将比较各组抑郁严重程度（如通过HAMD-24评估）和疼痛强度（如NRS、BPI）的变化以评估疗效。 次要结局指标包括疼痛感知、定量感觉测试、功能磁共振成像、脑磁图、代谢标志物、神经递质和炎症生物标志物。 本研究旨在提供精确、个体化的治疗策略，减少对药物治疗的依赖，并促进国产高端医疗设备的发展。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

160

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200072
        • 招聘中
        • Shanghai Tenth People's Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国、200030
        • 招聘中
        • Shanghai Mental Health Center
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  1. 年龄18-65岁；
  2. 符合ICD-11抑郁发作诊断标准，当前存在轻至中度抑郁症状（HAMD-24评分≥8且≤34）；
  3. 报告持续疼痛≥3个月，且简明疼痛量表（BPI）第5项评分≥4；
  4. 入组前至少四周维持稳定的抗抑郁药物及心理治疗方案（包括剂量、药物种类或治疗方式）；
  5. 右利手，听力正常，视力正常或矫正后正常；
  6. 能够自愿提供参与研究的书面知情同意，并愿意且有能力遵守所有研究程序。

排除标准：

  1. 诊断为其他精神障碍，包括精神分裂症谱系障碍、双相I型障碍（因存在躁狂发作风险及锂盐或抗惊厥药禁忌）、原发性焦虑障碍、与严重躯体疾病相关的抑郁等。
  2. 存在主动自杀意念，定义为HAMD-24第3项评分为4分。
  3. 重度或难治性抑郁（HAMD-24评分≥35，且当前抑郁发作持续至少2年，或当前发作期间对两种及以上抗抑郁治疗无效）。
  4. 过去3个月内存在物质使用障碍。
  5. 经历因癌症疼痛综合征、内脏痛（如胃痛）或牵涉痛（如胰腺炎引起的背痛）导致的恶性疼痛。
  6. 与脑结构异常相关的神经系统疾病（如创伤性脑损伤、近期脑卒中、脑肿瘤）。
  7. 过去3个月内接受过神经调控治疗，包括改良电休克治疗（MECT）、重复经颅磁刺激（rTMS）或经颅电刺激（tES）。
  8. 存在经颅电刺激禁忌症（如颅内金属植入物、心脏起搏器、人工耳蜗、刺激部位皮肤损伤、个人或家族癫痫史）。
  9. 当前或过去1个月内使用影响中枢神经系统兴奋性或疼痛的药物，如抗惊厥药、锂盐、阿片类药物、非甾体抗炎药及抗精神病药。允许按需偶尔使用对乙酰氨基酚作为急救药物，但必须在研究日记中详细记录。
  10. 存在痴呆或其他严重认知障碍迹象（MoCA评分<17）。
  11. 严重或不稳定的躯体疾病，包括但不限于：神经系统疾病（如癫痫、脑卒中、偏头痛、颅脑手术史）；心血管疾病（如未控制的高血压、心力衰竭、心律失常、心肌梗死）；呼吸系统疾病（如重度睡眠呼吸暂停综合征）；恶性肿瘤或免疫功能低下状态；未控制的糖尿病（空腹血糖>12 mmol/L）。
  12. 妊娠或哺乳期。
  13. 同时参与另一项临床试验、过去90天内参与过任何临床试验，或计划在研究期间参与其他试验。
  14. 存在任何磁共振成像禁忌症（如金属植入物、幽闭恐惧症、呼吸或运动功能障碍）。
  15. 无法配合研究评估。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：tDCS
Participants receive active tDCS. The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
设备：tDCS
Participants receive active tDCS. The anodal electrode (5 × 5 cm) is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode (5 × 7 cm) is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
实验性的：alpha-tACS
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).
设备：alpha-tACS
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).
假比较器：Sham
Sham group using the same electrode montage at F3/F4. To maintain blinding, the stimulator delivers current only during the initial 30-second ramp-up period, followed by an immediate ramp-down, and a final 30-second ramp-up at the end of the stimulation session. This mimics the initial sensation of active stimulation without delivering sufficient current to induce neural modulation.
设备：Sham
Sham group using the same electrode montage at F3/F4. To maintain blinding, the stimulator delivers current only during the initial 30-second ramp-up period, followed by an immediate ramp-down, and a final 30-second ramp-up at the end of the stimulation session. This mimics the initial sensation of active stimulation without delivering sufficient current to induce neural modulation.
实验性的：Exploratory Open-Label tACS Group
Participants in this exploratory arm receive the same active tACS intervention as Arm alpha-tACS, with identical stimulation parameters (e.g., 1 mA, 40 minutes, 10 Hz, targeting the bilateral dorsolateral prefrontal cortex (DLPFC)). This arm is open-label (unblinded): participants and study personnel are aware of the treatment assignment. It serves as a supplementary exploratory cohort to explore preliminary neural oscillation entrainment effects of tACS. Unlike Arms 1-3, this arm is neither randomized nor blinded. Data from this arm will be analyzed separately and are not included in the primary confirmatory hypothesis testing of the randomized controlled trial. The overall study remains double-blind for the three-arm RCT component, with this exploratory arm conducted as an ancillary cohort.
设备：alpha-tACS
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).

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
Proportion of Participants Achieving MCID on BPI Pain Intensity Subscale
大体时间：At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline

Description:

The BPI is a validated self-administered questionnaire that assesses the severity of pain and its impact on daily functioning. The pain intensity subscale consists of four items rating pain at its "worst," "least," "average," and "current" (right now). Each item is rated on a 0 to 10 numeric rating scale. Higher scores mean a worse outcome.

The Minimal Clinically Important Difference (MCID) is defined as a reduction of ≥ 1 point from baseline in the BPI pain intensity score. The outcome is the proportion of participants in each group who achieve this MCID threshold at each follow-up time point.
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline

次要结果测量

结果测量
措施说明
大体时间
Percentage Reduction from Baseline in HAMD-17 Total Score
大体时间：At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline

The HAMD-17 is a 17-item clinician-rated scale assessing depression severity. Items are rated on 3- or 5-point scales, with total scores ranging from 0 to 52. Higher scores mean a worse outcome (greater depression severity).

The outcome is the percentage reduction in HAMD-17 total score from baseline at each follow-up time point, calculated using the formula:

[(Baseline score - Follow-up score) / Baseline score] × 100%

A positive percentage indicates improvement (reduction in depressive symptoms).
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in HAMD-17 Total Score
大体时间：At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
The Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-rated scale assessing depression severity. Items are rated on 3- or 5-point scales, with total scores ranging from 0 to 52. Higher scores indicate greater depression severity (worse outcome). The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)]. A positive change value indicates improvement (reduction in depressive symptoms). No pre-defined clinically meaningful threshold is applied to this continuous outcome; it is reported as the mean absolute change per group.
At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Pain Catastrophizing Scale (PCS) Total Score
大体时间：At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
The Pain Catastrophizing Scale (PCS) is a 13-item self-reported questionnaire. Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (all the time), with total scores ranging from 0 to 52. Higher scores indicate higher levels of pain catastrophizing (worse outcome). The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)]. A positive change value indicates improvement (reduction in pain catastrophizing).
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Generalized Anxiety Disorder Scale-7 (GAD-7) Total Score
大体时间：At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
The GAD-7 is a 7-item self-report scale (0-21, higher scores = worse outcome) assessing anxiety symptoms over the past two weeks. The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)].
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Clinical Global Impression (CGI) Total Score
大体时间：At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)

The Clinical Global Impression (CGI) scale consists of two clinician-rated subscales assessing overall treatment response:

CGI-Severity (CGI-S): Rates the severity of the patient's illness on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores mean a worse outcome.

CGI-Improvement (CGI-I): Rates the patient's improvement compared to baseline on a 7-point scale from 1 (very much improved) to 7 (very much worse). This subscale is only assessed at post-baseline time points. Lower scores mean a better outcome (greater improvement).

The outcome is the change from baseline in CGI-S score at each follow-up time point, and the CGI-I score at each post-baseline time point.
At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Resting-State Functional Connectivity of the DLPFC at 2 Weeks
大体时间：Baseline and immediately after the 2-week intervention period
Resting-state functional connectivity (rs-FC) of the dorsolateral prefrontal cortex (DLPFC) is assessed using resting-state functional magnetic resonance imaging (rs-fMRI). The primary measurement is the change in seed-based functional connectivity strength between the DLPFC and its target network regions (e.g., parietal cortex, default mode network nodes), quantified as Fisher-transformed correlation coefficients (z-values) from a priori defined regions of interest. Higher z-values indicate stronger positive functional connectivity; lower or negative values indicate weaker or anticorrelated connectivity. Structural MRI (sMRI) is acquired for co-registration and normalization purposes.
Baseline and immediately after the 2-week intervention period

其他结果措施

结果测量
措施说明
大体时间
Change from Baseline in Brain-Derived Exosome Metabolite Levels
大体时间：From baseline to post-intervention at 2 weeks
Metabolite profiles are measured using untargeted liquid chromatography-mass spectrometry (LC-MS) in plasma-derived brain-enriched exosomes. Changes in metabolite profiles from baseline to post-intervention are assessed using multivariate partial least squares discriminant analysis (PLS-DA). The primary comparison is the separation distance (e.g., Q² or R² values) between baseline and post-intervention clusters, with positive values indicating greater separation between the two time points. This is an exploratory outcome to identify potential metabolic biomarkers and generate hypotheses related to the mechanisms of tACS/tDCS action. Results will be reported descriptively and are not part of the primary confirmatory analysis.
From baseline to post-intervention at 2 weeks
Change from Baseline in BPI Pain Intensity Score in the Exploratory Open-Label Cohort
大体时间：From baseline to post-intervention at 2 weeks
This exploratory outcome measures the change from baseline in the BPI Pain Intensity score after 10 sessions of active tACS in the open-label arm. Data are reported descriptively as individual change values, mean change, standard deviation, and within-group effect size (Cohen's d) . No formal hypothesis testing is planned; the results will inform effect size estimation for future trial planning.
From baseline to post-intervention at 2 weeks
Change from Baseline in HAMD-17 Total Score in the Exploratory Open-Label Cohort
大体时间：From baseline to post-intervention at 2 weeks
This exploratory outcome measures the change from baseline in HAMD-17 total score after 10 sessions of active tACS in the open-label arm. Data are reported descriptively as individual change values, mean change, standard deviation, and within-group effect size (Cohen's d). No formal hypothesis testing is planned; the results will inform effect size estimation for future trial planning.
From baseline to post-intervention at 2 weeks
Change from Baseline in GAD-7 Total Score in the Exploratory Open-Label Cohort
大体时间：From baseline to post-intervention at 2 weeks
This exploratory outcome measures the change from baseline in GAD-7 total score after 10 sessions of active tACS in the open-label arm. Data are reported descriptively as individual change values, mean change, standard deviation, and within-group effect size (Cohen's d). No formal hypothesis testing is planned. GAD-7 scores will also be explored as a covariate in pain outcome analyses.
From baseline to post-intervention at 2 weeks
Change from Baseline in Resting-State EEG Power Spectra in the Exploratory Open-Label Cohort
大体时间：Baseline, Day 1 (immediately before and after the 1st tACS session), Day 10 (immediately before and after the 10th tACS session), and Day 11 (on the day after completion of all 10 sessions)
Resting-state EEG is recorded for 5 minutes with eyes open and 5 minutes with eyes closed using a 64-channel EEG system. The primary measure is the change from baseline in spectral power (absolute and relative) across frequency bands (delta: 1-4 Hz, theta: 4-8 Hz, alpha: 8-12 Hz, beta: 12-30 Hz, gamma: 30-50 Hz), with a focus on the alpha band (8-12 Hz) due to the 10 Hz tACS intervention. Data are analyzed descriptively without formal hypothesis testing.
Baseline, Day 1 (immediately before and after the 1st tACS session), Day 10 (immediately before and after the 10th tACS session), and Day 11 (on the day after completion of all 10 sessions)
Change from Baseline in Task-State EEG (Event-Related Potentials) in the Exploratory Open-Label Cohort
大体时间：Baseline and Day 11 (on the day after completion of all 10 tACS sessions)
Task-state EEG is recorded while participants perform a cognitive task (e.g., working memory or attention task). The primary measure is the change from baseline in event-related potential (ERP) components and task-related spectral power changes (event-related desynchronization/synchronization). Data are analyzed descriptively without formal hypothesis testing.
Baseline and Day 11 (on the day after completion of all 10 tACS sessions)
Change from Baseline in Resting-State EEG Functional Connectivity in the Exploratory Open-Label Cohort
大体时间：Baseline and Day 11 (on the day after completion of all 10 sessions)
Resting-state EEG functional connectivity is assessed using coherence and phase-locking value (PLV) between electrode pairs, with a focus on the alpha band and the DLPFC region. Data are analyzed descriptively without formal hypothesis testing.
Baseline and Day 11 (on the day after completion of all 10 sessions)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Mental Health Center

合作者

Shanghai 10th People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年1月3日

首先提交符合 QC 标准的

2026年1月3日

首次发布 (实际的)

2026年1月12日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2025-80

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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