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正在招募不适用编号 NCT07818668

tACS for Self-Other Boundary in Schizophrenia

报名条件(概要)

  • 年龄:18 Years – 50 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

药品与企业信息

Transcranial Alternating Current Stimulation (tACS)医疗器械

10Hz tACS with 2mA intensity, 20 minutes per day

Sham Transcranial Alternating Current Stimulation (tACS)医疗器械

Sham stimulation with identical electrode placement and procedures as the active tACS group. Current is delivered only during the 30-second ramp-up and ramp-down periods, with no active stimulation for the remainder of the 20-minute session.

研发企业

Chunyan Zhu研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

This clinical trial investigates whether a non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) can improve the ability to distinguish between "self" and "others" in patients with schizophrenia. The intervention targets the medial prefrontal cortex (mPFC), a brain region critical for self-awareness, using 10Hz stimulation at 2mA for 20 minutes daily over five consecutive days. The study has two main objectives. First, it aims to characterize the underlying mechanisms of self-other boundary dysfunction in schizophrenia by comparing behavioral and brain activity patterns among three participant groups: patients with schizophrenia, individuals with high schizotypal traits, and healthy volunteers. During this mechanism phase, participants perform two computer-based self-other face recognition tasks designed to manipulate prior probability (varying the proportion of self vs. other faces across blocks) and perceptual uncertainty (adjusting the Gaussian blur level of face images), while their brain activity is recorded via EEG. Behavioral performance (response time, accuracy, and sensitivity d') and EEG markers (alpha-band power, N170, and P1 components) are analyzed to quantify deficits in predictive coding. Second, the study aims to evaluate the therapeutic efficacy of tACS in a randomized, double-blind, sham-controlled trial. The primary hypothesis is that active tACS, compared to sham stimulation, will significantly improve patients' accuracy in distinguishing self from other faces, accompanied by enhanced alpha-band brain oscillations and reduced scores on the Examination of Anomalous Self-Experience (EASE) scale. All participants will undergo clinical assessments, complete the face recognition tasks while their brain activity is monitored via EEG, and complete follow-up assessments 48 hours after the last stimulation session. The findings from this study may provide a novel, mechanism-based non-pharmacological intervention for addressing core self-disturbance in schizophrenia, potentially improving patients' social functioning and quality of life.

适应症

Schizophrenia / Schizoaffective Disorder

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: tACS for Self-Other Boundary in Schizophrenia
ClinicalTrials.gov Identifier: NCT07818668
Sponsor: Chunyan Zhu
Investigational product: Transcranial Alternating Current Stimulation (tACS), Sham Transcranial Alternating Current Stimulation (tACS)

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:tACS for Self-Other Boundary in Schizophrenia
试验编号:NCT07818668
申办方:Chunyan Zhu
研究药物:Transcranial Alternating Current Stimulation (tACS)、Sham Transcranial Alternating Current Stimulation (tACS)

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 chen37213@163.com

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面