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A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia (dTMS)

2026年9月1日 更新者：Ping Shao、Second Xiangya Hospital of Central South University

The Study of Improving Antipsychotic-induced Appetite by Deep Transcranial Magnetic Stimulation: The Effects of Improving Antipsychotic-induced Appetite by Single Session dTMS After Food Cue-induced Craving, A Randomized, Crossover and Sham-Controlled Trail

Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. Furthermore, it is reported significant changes in food intake happened in patients with weight gain after intaking antipsychotics. There are no hitherto effective treatments for reducing antipsychotic-induced weight gain. dTMS which is a safe and non-invasive physical treatment indicates greater efficacy than other transcranial magnetic stimulation (TMS) by some research. Apart from that, symptom provocation is believed to improve the clinical responses to TMS. In this study, the investigators, firstly, evaluate the safety and effectiveness of dTMS for reducing antipsychotic-induced weight gain and secondly, unveil whether symptom provocation can affect the clinical responses to TMS.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The underlying causes of antipsychotic-induced weight gain are still unknown. Some research point out that it has something to do with metabolic disturbances and changes in appetite and food intake. With fMRI study, it is reported having dysfunction between prefrontal and insula cortex of its cognitive regulation, interoceptive signals and reward control. dTMS, H4 coil in particular, simultaneously targets prefrontal and insula cortex. Previous study has been deconstrued that dTMS could significantly improve weight gain. Moreover, it is reckoned that TMS has state-dependent effects on brain circuitry, suspected that symptom provocation may be made it more susceptible to modulation which may improve response. Therefore, this study is to explore the efficacy of dTMS on antipsychotic-induced appetite, and whether provoking symptoms can improve dTMS clinical responses.

With regard to investigate this, the investigators will be carried out a randomized single session dTMS, crossover, sham controlled clinical trial. 30 Patients with schizophrenia will be randomly treated with dTMS after food cue induced craving (FCC), dTMS without FCC and sham condition without FCC. Each session has three days intervals for washout. The follow-ups are at the baseline and after each session immediately. The main outcome measures include the change in Food-Cravings Questionnaires state (FCQ-S) score, Visual Analogue Scale (VAS) score, changes in Stop-Signal test (SST) behavioral assessment and the resting-state functional magnetic resonance imaging data.

研究类型

介入性

注册 (估计的)

30

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：Ping Shao
  • 电话号码：+86-13755112445
  • 邮箱：shp97jw@163.com

研究联系人备份

学习地点

  • 中国
    • Hunan
      • Changsha、Hunan、中国、410011
        • The Second Xiangya Hospital of Central South University
        • 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

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged between 18-60
  • Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
  • Gaining body weight around 7% after intaking antipsychotics within 2 years
  • Participants were on a stable medication regimen at the time of enrollment
  • Written informed consent was obtained from both the participants and their legally authorized guardians

Exclusion Criteria:

  • Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.
  • Diagnosed with other mental diseases in accordance with DSM-V
  • Comorbid with other severe physiological diseases
  • Active suicidal ideation
  • A history of alcohol or substance use disorder (or abuse)
  • Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI)
  • Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation
  • Receipt of regular repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month
  • Pregnant or lactating women

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：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Active dTMS after food cue induced craving (dTMS+FCC)
Participants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after food cue induced craving by watching the personalized video based on each participant's favorite food choices
设备：Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active
The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS). The stimulation intensity is set at 90% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
有源比较器：Active dTMS after non food cue induced craving (dTMS+NON FCC)
Participants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
设备：Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active
The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS). The stimulation intensity is set at 90% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
假比较器：Sham dTMS after non food cue induced craving (SHAM dTMS+NON FCC)
Participants will receive single session of sham-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
设备：深部经颅磁刺激 (dTMS) H4 线圈 - 假手术
该研究将采用相同的方案，使用 H4 线圈来管理假条件。

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
Food Craving Questionnaire State, FCQ-S
大体时间：Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
The assessment of food cravings. The FCQs consists of 15 items to be scored on a 5-point scale ranging from strongly disagree to strongly agree. Its original form comprises five subscales measuring current food craving in relation to (1) an intense desire to eat, (2) anticipation of positive reinforcement, (3) relief from negative states, (4) lack of control over eating, and (5) hunger.
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)

次要结果测量

结果测量
措施说明
大体时间
Visual Analogue Scale, VAS
大体时间：Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
The Visual Analogue Scales required the subjects to rate hunger, satiety, thirst, fullness and emptiness on a 0-100 mm scale. The Visual Analogue Scales of Craving was assessed two times: before the provocation procedure, and after the provocation procedure
Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
Changes of Stop-Signal mean reaction time (SSRT)
大体时间：Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
The SST aims to access cognitive behavioral inhibition control. The study employed a task that comprised randomly interleaved NoGo and Stop-Signal trials to examine both types of inhibition. The study measured six behavioral parameters of interest: namely Mean Go reaction time (GoRT), Stop-Signal mean reaction time (SSRT), Stop-Signal delay (SSD), Target accuracy, Go trial accuracy, and NoGo Accuracy. The SST main outcome is the changes of Stop-Signal mean reaction time (SSRT)
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Resting-state functional magnetic resonance imaging
大体时间：Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Task-state functional magnetic resonance imaging
大体时间：Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Measure of the immediate activation (blood-oxygen-level-dependent change) in the brain regions related to appetite neural circuits under food cue reactivity task
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)

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

Second Xiangya Hospital of Central South University

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)

2027年5月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年8月26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8日

研究记录更新

最后更新发布 (实际的)

2026年9月8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

关键字

其他相关的 MeSH 术语

其他研究编号

  • LYEC2026-0195
  • 82571770 (其他赠款/资助编号：National Natural Science Foundation of China)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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