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Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease (STN-tTIS-PD)

Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial

Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).

研究概览

详细说明

This is a single-center, randomized, double-blind, sham-controlled trial for Parkinson's disease (PD). The transcranial temporal interference stimulation (tTIS) intervention period is 5 days, with follow-up assessments conducted immediately after the intervention, 10 days post-intervention, and 30 days post-intervention. The real stimulation group receives bilateral subthalamic nucleus (STN) -targeted tTIS once daily for 5 days. Stimulation parameters: carrier frequencies of 2000/2130 Hz (Δf = 130 Hz), with stimulation lasting 20 minutes on each side. Before the intervention, T1-weighted structural images are acquired for each subject, and computational modeling based on an individual head model is performed to optimize electrode placement, individually focusing on the target side STN region. The sham group follows the same procedure but does not receive effective stimulation. The sham stimulation group receives only 30 seconds of fade-in/fade-out current at the beginning and end of the stimulation period to ensure blinding.

研究类型

介入性

注册 (估计的)

32

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

研究联系人备份

学习地点

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200080
        • 招聘中
        • Shanghai General Hospital
        • 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

Inclusion Criteria:

  • Aged 50-85 years, male or female.
  • Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.
  • Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.
  • Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.
  • Written informed consent signed by the study participant.

Exclusion Criteria:

  • Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.
  • Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.
  • Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.
  • Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.
  • Presence of contraindications to MRI or inability to tolerate MRI examination.
  • Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance.
  • New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks.
  • History of epilepsy.
  • Pregnancy or breastfeeding.
  • Any other condition judged by the investigator as unsuitable for participation in the study.

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:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:the experimental group
real stimulation
tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
假比较器:the control group
sham stimulation
The sham stimulation is administered using the same procedure as the real tTIS.

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
Changes of motor function in PD
大体时间:Changes from baseline after 5 days of intervention (Day 5)
the scores of UPDRS III [OFF])
Changes from baseline after 5 days of intervention (Day 5)

次要结果测量

结果测量
措施说明
大体时间
Changes of motor function in PD
大体时间:Day 15, Day 35 (UPDRS III [OFF] ); Day 5, Day 15, Day 35 (UPDRS III [ON])
the scores of UPDRS III [OFF] and [ON]
Day 15, Day 35 (UPDRS III [OFF] ); Day 5, Day 15, Day 35 (UPDRS III [ON])
Changes of Motor Complications in PD
大体时间:Day 5, Day 15, Day 35
the scores of UPDRS IV
Day 5, Day 15, Day 35
Assessment of changes in cognition
大体时间:Day 5, Day 15, Day 35
the scores of MoCA
Day 5, Day 15, Day 35
Assessment of changes in anxiety
大体时间:Day 5, Day 15, Day 35
the scores of HAMA
Day 5, Day 15, Day 35
Assessment of changes in depression
大体时间:Day 5, Day 15, Day 35
the scores of HAMD
Day 5, Day 15, Day 35
Assessment of changes in sleep
大体时间:Day 5, Day 15, Day 35
the scores of PSQI
Day 5, Day 15, Day 35
Assessment of changes in daytime sleepiness
大体时间:Day 5, Day 15, Day 35
the scores of ESS
Day 5, Day 15, Day 35
Assessment of changes in RBD
大体时间:Day 5, Day 15, Day 35
the scores of RBDSQ
Day 5, Day 15, Day 35
Assessment of changes in RLS
大体时间:Day 5, Day 15, Day 35
the scores of IRLSRS
Day 5, Day 15, Day 35
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
大体时间:Day 5, Day 15, Day 35
the scores of UPDRS I
Day 5, Day 15, Day 35
Assessment of changes in Motor Aspects of Experiences of Daily Living
大体时间:Time Frame: Day 5, Day 15, Day 35
the scores of UPDRS II
Time Frame: Day 5, Day 15, Day 35

其他结果措施

结果测量
措施说明
大体时间
Changs of brain connectivity in the PD brain
大体时间:After 5 days of intervention relative to baseline
functional magnetic resonance imaging (fMRI)
After 5 days of intervention relative to baseline

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 (实际的)

2026年5月20日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • Shanghai1st-2026-tTIS
  • No. 02.06.02.26.19 (其他赠款/资助编号:Basic and Clinical Collaborative Research Program of Shanghai General Hospital)

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

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