使用高清经颅直流电刺激治疗帕金森病的认知和感觉运动缺陷
2026年9月14日 更新者：John Hart, Jr.、The University of Texas at Dallas
使用高清经颅直流电刺激治疗帕金森病的认知与感觉运动缺陷
本研究旨在检查经颅直流电刺激（tDCS）对言语检索、认知、感觉运动控制的影响，并确定tDCS是否可作为改善帕金森病（PD）患者检索、感觉和运动能力的方法。
研究概览
详细说明
目的：基于我们团队开发的语义记忆检索模型，其中背内侧额叶的前辅助运动区（preSMA）起着重要作用，我们提出通过在前辅助运动区应用高清经颅直流电刺激（HD tDCS）来治疗帕金森病（PD）的认知缺陷，以改善支持言语检索的神经回路功能。 此外，由于前辅助运动区涉及运动规划和序列化，我们也在探索在前辅助运动区应用高清经颅直流电刺激是否会对言语和步态产生影响。
具体目标：
- 通过使用高清经颅直流电刺激调节前辅助运动区，研究其对言语检索功能的治疗效果。
- 通过使用高清经颅直流电刺激调节前辅助运动区，研究其对言语产生和处理的治疗效果。
- 通过使用高清经颅直流电刺激调节前辅助运动区，研究其对步态和平衡的治疗效果。
假设：
- ：与假刺激相比，主动高清经颅直流电刺激（对前辅助运动区施加1毫安阳极高清经颅直流电刺激）将改善言语流畅性（即，在控制性词语联想测试中的音位流畅性和类别流畅性）作为主要结果指标。
- ：与假刺激相比，主动高清经颅直流电刺激（对前辅助运动区施加1毫安阳极高清经颅直流电刺激）将改善言语序列化。
- ：与假刺激相比，主动高清经颅直流电刺激（对前辅助运动区施加1毫安阳极高清经颅直流电刺激）将改善一般运动序列化。
研究类型
介入性
注册 (估计的)
20
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：Michael A Motes, PhD
- 电话号码：972-883-4846
- 邮箱：michael.motes@utdallas.edu
学习地点
-
-
Texas
-
Richardson、Texas、美国、75080
- 招聘中
- Callier Clinical Center, The University of Texas at Dallas
-
接触：
- Michael A Motes, PhD
- 电话号码：972-883-4846
- 邮箱：michael.motes@utd.edu
-
首席研究员：
- John Hart, Jr, MD
-
首席研究员：
- Saul A Frankford, PhD
-
-
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
纳入标准：
- 诊断为帕金森病（PD）且存在语言流畅性缺陷
- 年龄50-90岁
- 能够理解并签署知情同意书（能够回答同意理解问题）
- 英语口语和阅读流利
排除标准：
- 可能存在混淆的心理或神经系统疾病，包括癫痫或其他癫痫发作性疾病；严重创伤性脑损伤（基于俄亥俄州TBI识别方法）；脑肿瘤；中风；当前药物滥用/误用；或亨廷顿病。在PI诊所就诊的参与者将作为标准临床评估的一部分接受这些问题评估。
- 此外，排除标准包括影响经颅直流电刺激（tDCS）实施的颅骨植入物或颅骨缺损；以及使用与tDCS效应相互作用或可能相互作用的药物，包括抗惊厥药、卡马西平、舒必利、培高利特、劳拉西泮、利斯的明、右美沙芬、D-环丝氨酸、氟桂利嗪、罗匹尼罗或西酞普兰。
- 仅诊断为构音障碍或装有深部脑刺激（DBS）设备的患者将被排除。
- 此外，非英语使用者将被排除，因为并非所有筛选表格、问卷和测试都有英语以外的语言版本。
- 认知功能受损的个体（蒙特利尔认知评估得分≤22分）将考虑排除，因其同意能力可能降低。得分≤22分的参与者仅在有陪同研究伙伴/护理人员陪同，且能同时获得参与者及其陪同研究伙伴/护理人员（需为参与者的配偶、成年子女、父母或成年兄弟姐妹）的书面同意时方可参与。若无陪同研究伙伴/护理人员，则当时不得参与。但允许其后续携带陪同研究伙伴/护理人员返回，按上述流程完成同意程序和研究。
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 |
|---|---|
|
假比较器：假手术经颅直流电刺激
假手术经颅直流电刺激将通过 Neuroelectrics Starstim tES 进行。
假手术设置将包括阳极电极 Fz（用于脑电图电极放置的国际 10/10 系统）和作为返回的电极 F7、FP1、FP2 和 F8。
所有电极均为直径 1 厘米的 Ag/AgCl 电极，并通过连接凝胶与头皮接触。
刺激将在 60 秒内从 0 毫安线性上升至 1 毫安，在 60 秒内下降至 0 毫安，然后停止 20 分钟。
|
假手术经颅直流电刺激将通过 Neuroelectrics Starstim tES 进行。
假手术设置将包括阳极电极 Fz（用于脑电图电极放置的国际 10/10 系统）和作为返回的电极 F7、FP1、FP2 和 F8。
所有电极均为直径 1 厘米的 Ag/AgCl 电极，并通过连接凝胶与头皮接触。
刺激将在 60 秒内从 0 毫安线性上升至 1 毫安，在 60 秒内下降至 0 毫安，然后停止 20 分钟。
其他名称：
|
|
实验性的：经颅直流电刺激
经颅直流电刺激将通过Neuroelectrics Starstim tES设备进行。
刺激将采用1毫安电流，阳极刺激施加于电极Fz（国际10/10系统脑电图电极放置位置），并以F7、FP1、FP2和F8电极作为回路。
所有电极为直径1厘米的Ag/AgCl电极，通过导电凝胶与头皮接触。
刺激电流将在60秒内从0毫安线性上升至1毫安，随后在20分钟内保持1毫安刺激，最后在60秒内线性下降至0毫安。
其他名称：tDCS 1毫安 tDCS 高精度tDCS 高精度经颅直流电刺激仪，Neuroelectrics Starstim tES，SN E20200930-10
|
经颅直流电刺激将通过Neuroelectrics Starstim tES设备进行。
刺激参数为1毫安电流，阳极刺激通过Fz电极（国际10/10系统脑电图电极放置标准）施加，并以F7、FP1、FP2和F8电极作为回路电极。
所有电极均为直径1厘米的Ag/AgCl电极，通过导电凝胶与头皮接触。
刺激电流将在60秒内从0毫安线性上升至1毫安，随后在20分钟内保持1毫安刺激强度，最后在60秒内线性下降至0毫安。
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 |
|---|---|---|
|
Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
valuation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment.
Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment.
Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
|
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-Treatment on Phonemic Fluency
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 1-week post-treatment.
Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Phonemic Fluency
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 2-months post-treatment.
Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
|
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during overt reading
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment.
Metric: syllables per second on a passage reading task (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during overt reading
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment.
Metric: Syllables per second during a reading passage (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during self-generated speech
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment.
Metric: Syllables per second during self-generated speech (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during self-generated speech
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment.
Metric: Syllables per second during self-generated speech (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 1-week post-treatment.
Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-month Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 2-month post-treatment.
Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)
|
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during overt reading
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment.
Metric: coefficient of variation of syllable duration on a passage reading task (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during overt reading
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment.
Metric: Coefficient of variation of syllable duration during a reading passage (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during self-generated speech
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment.
Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during self-generated speech
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment.
Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during overt reading
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment.
Metric: Pause time as percentage of total speaking time on a passage reading task (minimum=0%; maximum=100%).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during overt reading
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment.
Metric: Pause time as percentage of total speaking time during a reading passage (minimum=0%; maximum=100%).
|
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during self-generated speech
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment.
Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during self-generated speech
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment.
Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).
|
Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
|
|
Treatment group differences in change from Baseline to 1-week Post-treatment on Freezing of Gate during the timed up and go task
大体时间：Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
Evaluation of treatment group differences in change in freezing of gate from baseline to 1-week post-treatment.
Metric: Timed up and go time (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-month Post-treatment on Freezing of Gate during the timed up and go task
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in freezing of gate from baseline to 2-month post-treatment.
Metric: Timed up and go time (minimum=0; no maximum).
|
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
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
- 首席研究员：John Hart, MD、Callier Clinical Research Center, The University of Texas at Dallas
- 首席研究员：Saul A Frankford, PhD、Callier Clinical Research Center, The University of Texas at Dallas
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9月15日
初级完成 (估计的)
2027年10月31日
研究完成 (估计的)
2027年10月31日
研究注册日期
首次提交
2026年4月9日
首先提交符合 QC 标准的
2026年4月9日
首次发布 (实际的)
2026年4月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB-26-35
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
De-identified individual participant data (IPD) that underlie the results reported in published articles, including baseline demographic and clinical characteristics required to replicate the findings, will be made available.
IPD 共享时间框架
Beginning 6 months and ending 36 months following publication.
IPD 共享访问标准
Access will be provided via email request to the corresponding author or through the designated repository required by the publishing journal.
IPD 共享支持信息类型
- 研究方案
- 树液
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
是的
在美国制造并从美国出口的产品
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.