Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) for Patients With Obsessive-Compulsive Disorders
2026年9月1日 更新者：Xiang Yang Zhang、Beijing HuiLongGuan Hospital
Individualized Targeted Transcranial Temporal Interference Stimulation for for Patients With Obsessive-Compulsive Disorders: A Double-Blinded, Randomized Controlled Trial
Targeted temporal interference stimulation (tTIS) of the nucleus accumbens (NAc) may modulate the abnormal electrophysiological activity in individuals with obsessive-compulsive disorder (OCD), thereby improving their obsessive-compulsive symptoms.
研究概览
详细说明
This study will investigate the therapeutic effects and potential neural mechanisms of targeted temporal interference stimulation (tTIS) of the nucleus accumbens in individuals with obsessive-compulsive disorder (OCD).
Participants will receive either active or sham tTIS for 5 consecutive days.
Clinical symptoms will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and additional psychological questionnaires at baseline, immediately after the intervention, and during follow-up assessments.
Behavioral tasks, including instrumental learning and probabilistic reversal learning paradigms, will be administered to assess intervention-related changes in behavioral performance.
Resting-state electroencephalography (EEG) and multimodal magnetic resonance imaging (MRI) will be acquired before and after the intervention to evaluate intervention-related changes in brain function and structure.
The study aims to evaluate the clinical efficacy of nucleus accumbens-targeted tTIS and to explore its potential behavioral and neurobiological mechanisms in OCD.
研究类型
介入性
注册 (估计的)
80
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
- 姓名：Xiang-yang Zhang
- 电话号码：18513299860
- 邮箱：zhangxy99@mail.tsinghua.edu.cn
学习地点
-
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Anhui
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Hefei、Anhui、中国、230000
- 招聘中
- The Fourth People's Hospital of Anhui Province
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接触：
- Zhang Xiang-yang
- 电话号码：18513299860
- 邮箱：zhangxy99@mail.tsinghua.edu.cn
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接触：
-
首席研究员：
- Xinyue Zhang
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-
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
Inclusion Criteria:
- Were between 18 and 65 years old;
- Were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
- Were able to participate in the entire trial and face-to-face on-site assessment
Exclusion Criteria:
- Pregnant or breastfeeding;
- Suffered from organic brain diseases or severe physical illness;
- Had a history of substance or alcohol abuse;
- Presence of comorbid psychiatric disorders (e.g., major depressive disorder) or a high risk of suicide;
- Have received electroconvulsive therapy, transcranial magnetic stimulation, tDCS, tACS, or other neurostimulation treatments within the past 6 months;
- Presence of contraindications to MRI or tTIS, such as severe head trauma, prior brain surgery, intracranial or cardiac metallic implants, etc.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nucleus accumbens group (tTIS)
Participants assigned to the active tTIS group will receive temporal interference stimulation targeting the right nucleus accumbens (NAc).
Individualized electrode configurations will be determined based on each participant's structural MRI.
Two high-frequency alternating currents at 2000 Hz and 2130 Hz will be applied, with a peak current intensity of up to 2 mA for each stimulation channel.
Each stimulation session will last 30 minutes and will include a 30-second linear ramp-up at the beginning and a 30-second linear ramp-down at the end.
Electrode impedance will be maintained below 8 kΩ.
Stimulation will be administered twice daily for 5 consecutive days, with an interval of approximately 90-120 minutes between the two daily sessions.
|
Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain.
The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
其他名称：
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假比较器：Control Group
Participants assigned to the sham control group will undergo the same procedures and stimulation settings as those in the active tTIS group, including electrode placement, stimulation frequencies, nominal current intensity, ramp-up and ramp-down phases, session duration, and treatment schedule.
However, no therapeutic stimulation current will be delivered.
|
Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain.
The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
其他名称：
|
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 |
|---|---|---|
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Obsessive-compulsive symptoms
大体时间：Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
The Y-BOCS total score ranges from 0 to 40, with higher scores indicating greater symptom severity.
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Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-reported obsessive-compulsive symptoms
大体时间：Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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The reduction rate of the score of Obsessive-Compulsive Inventory-Revised (OCI-R), a self-rating scale of OCD symptoms severity, was employed as a secondary outcome.
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Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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Multimodal MRI measures
大体时间：Baseline, after completion of 5-day intervention
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Multimodal MRI data will be acquired at baseline and after completion of the 5-day intervention using a 3.0-T MRI scanner.
The imaging protocol includes T1-weighted and T2-weighted structural MRI, resting-state blood-oxygen-level-dependent (BOLD) functional MRI, and diffusion-weighted imaging (DWI).
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Baseline, after completion of 5-day intervention
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Resting-state electroencephalography (EEG) measures
大体时间：Baseline, after completion of 5-day intervention
|
Resting-state EEG will be recorded at baseline and after completion of the 5-day intervention.
Changes in EEG-derived neurophysiological measures between baseline and post-intervention will be assessed to characterize intervention-related alterations in brain activity.
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Baseline, after completion of 5-day intervention
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Behavioral task performance
大体时间：Baseline, after completion of the 5-day intervention
|
Behavioral task performance will be assessed at baseline and after the 5-day intervention using computerized cognitive tasks.
Task-derived behavioral measures, such as instrumental learning tasks and probabilistic reversal learning tasks, will be analyzed to evaluate intervention-related changes in behavioral performance.
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Baseline, after completion of the 5-day intervention
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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。
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10月16日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月1日
首次发布 (实际的)
2026年9月4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
2026年9月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Deidentified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request and approval by the principal investigator and relevant institutional authorities.
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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