Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients
2026年8月31日 更新者：Shanghai Mental Health Center
Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control.
Stimulation will be delivered in real time according to each patient's cue-induced response time.
研究概览
详细说明
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
研究类型
介入性
注册 (估计的)
50
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：Min Zhao, PhD
- 电话号码：64387250
- 邮箱：drminzhao@gmail.com
研究联系人备份
- 姓名：Tianzhen Chen, PhD
- 邮箱：vomchan@hotmail.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- Shanghai Mental Health Center
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接触：
- Min Zhao, Phd
- 电话号码：64387250 18017311005
- 邮箱：drminzhao@smhc.org.cn
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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
接受健康志愿者
不
描述
Inclusion Criteria:
- Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
Exclusion Criteria:
- Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
- A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- Severe organic diseases that might compromise study participation.
- Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
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 |
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假比较器：对照组
刺激参数——包括频率、电流强度和持续时间——与主动组完全相同。
然而，设备激活了伪刺激模式，导致在刺激期间没有实际电流输出。
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The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group.
However, the sham stimulation mode is activated on the device, resulting in consist of a 5-s current ramp-up, but 0 s of continuous stimulation during the stimulation.
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实验性的：Temporal Interference Stimulation Group
The first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz.
Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region.
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Each session will comprise 240 trials, during which stimulation may be triggered up to 10 times according to the participant's cue-reactivity state.
Each stimulation will consist of a 5-s current ramp-up, 30 s of continuous stimulation, and a 5-s current ramp-down.
The intervention will be administered once daily for five consecutive days.
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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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Change of Craving
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Visual Analog Scale, range0-100 point.
the higher the score, the more one wants drugs.
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baseline, 1 day after treatment, 1 month after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Obsessive-Compulsive Drug Use Scale score
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Drug-related obsessive thoughts and compulsive behaviours will be assessed using the Obsessive-Compulsive Drug Use Scale (OCDUS).
The scale consists of 14 items rated from 0 to 4, producing a total score ranging from 0 to 56.
Higher scores indicate more severe drug-related obsessive thoughts, craving, and impaired control over drug use.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Impulsive System score
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Impulsive tendencies will be assessed using the Impulsive System subscale of the Dual-Mode of Self-Control Scale (DMSC-S).
The subscale contains 12 items rated from 1 to 5, producing a total score ranging from 12 to 60. Higher scores indicate stronger impulsive-system tendencies, including greater impulsivity, distractibility, and preference for immediate gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Control System score
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Self-control will be assessed using the Control System subscale of the Dual-Mode of Self-Control Scale (DMSC-S).
The subscale contains 9 items rated from 1 to 5, producing a total score ranging from 9 to 45. Higher scores indicate stronger self-control, including better problem-solving and future-oriented planning.
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baseline, 1 day after treatment, 1 month after treatment
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Stop Single Task
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Response inhibition will be assessed using the Stop-Signal Task.
The primary behavioural parameter will be the reaction time and accuracy, measured in milliseconds.
A longer stop-signal reaction time indicates poorer inhibitory control, whereas a shorter stop-signal reaction time indicates better inhibitory control.
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baseline, 1 day after treatment, 1 month after treatment
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EEG ERP amplitude during the Stop-Signal Task
大体时间：baseline, 1 day after treatment, 1 month after treatment
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The mean amplitude of the stop-related event-related potential and functional connection will be measured in microvolts over frontocentral electrodes within the prespecified post-stimulus time window.
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baseline, 1 day after treatment, 1 month after treatment
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Decision-making Preferences and Delay of Gratification
大体时间：baseline, 1 day after treatment, 1 month after treatment
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delay discounting task,Delay of gratification will be assessed using a computerised delay-discounting task in which participants choose between smaller immediate rewards and larger delayed rewards.
The discounting-rate parameter, k, will be estimated from participants' choices.
A higher k value indicates steeper delay discounting, a stronger preference for immediate rewards, and a lower ability to delay gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Changes in Reward Learning
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Reward learning will be assessed using a computerised reinforcement-learning task.
A computational reinforcement-learning model will be fitted to participants' trial-by-trial choices.
The learning-rate parameter, alpha, ranges from 0 to 1 and represents the extent to which recent feedback is used to update expected values.
Higher values indicate greater updating in response to recent feedback.
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baseline, 1 day after treatment, 1 month after treatment
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sensitivity to reward and punishment
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to punishment will be assessed using the Sensitivity to Punishment subscale of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ).
The subscale contains 24 dichotomous items scored 0 or 1, producing a score ranging from 0 to 24.
Higher scores indicate greater sensitivity to punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Behavioral Inhibition/Activation System Scale
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to anticipated punishment will be assessed using the 7-item Behavioural Inhibition System subscale of the Behavioural Inhibition System/Behavioural Activation System Scales.
Each item is rated from 1 to 4, producing a score ranging from 7 to 28.
Higher scores indicate greater behavioural inhibition and sensitivity to anticipated punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Beck Depression Inventory-II score
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Depressive symptom severity will be assessed using the Beck Depression Inventory-II (BDI-II).
The inventory consists of 21 items rated from 0 to 3, producing a total score ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
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baseline, 1 day after treatment, 1 month after treatment
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Drug-cue Flanker task
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Attentional interference from methamphetamine-related cues will be assessed using a computerised drug-cue Flanker task.
The drug-cue attentional interference effect will be calculated as the difference in mean reaction time between trials containing methamphetamine-related cues and trials containing neutral cues, measured in milliseconds.
A larger positive value indicates greater attentional interference from methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG theta power
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Theta-band power will be quantified within the prespecified frequency range, electrode region, and post-stimulus time window.
The cue-related theta effect will be calculated as the difference between methamphetamine-related and neutral cue conditions.
A larger value indicates a stronger theta-band response to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG P3 amplitude
大体时间：baseline, 1 day after treatment, 1 month after treatment
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Task-related electroencephalography will be recorded during the drug-cue Flanker task and the reward learning task.
The mean amplitude of the P3 event-related potential will be measured in microvolts within the prespecified electrode region and post-stimulus time window.
A larger positive difference indicates greater neural reactivity to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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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。
调查人员
- 学习椅：Min Zhao, PhD、Shanghai Mental Health Center
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9月1日
初级完成 (估计的)
2026年10月30日
研究完成 (估计的)
2026年11月1日
研究注册日期
首次提交
2026年7月30日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月3日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年7月1日
更多信息
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.