针对 COVID-19 (PASC) 急性后遗症的居家脑刺激治疗
2026年6月29日 更新者:Hamdi Eryilmaz, PhD、Massachusetts General Hospital
基于家庭的经颅直流电刺激 (tDCS) 治疗 COVID-19 (PASC) 的认知急性后遗症
本研究的主要目标是通过家庭经颅直流电刺激 (tDCS) 改善表现出 COVID-19 (PASC) 急性后遗症患者的执行障碍症状(例如,持续注意力、处理速度),这是一种无创方法,可使用通过头皮上的刺激电极输送到大脑的低强度电流。
研究概览
研究类型
介入性
注册 (实际的)
31
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。
学习地点
-
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Massachusetts
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Charlestown、Massachusetts、美国、02129
- Massachusetts General Hospital
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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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准:
- 提供知情同意的能力
- 根据过去的 COVID-19 感染和持续症状(包括“脑雾”、意识模糊、短期记忆缺陷、注意力不集中、精神错乱、多任务处理困难)表明的 PASC 诊断。
排除标准:
- 癫痫史
- 头部和颈部的金属植入物,
- 大脑刺激器
- 心脏起搏器
- 怀孕
- 活性物质依赖(烟草除外)
- 病前重大神经系统疾病
- 严重的精神疾病(例如双相情感障碍、精神分裂症)
- 注意力缺陷多动障碍
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:主动 tDCS
该小组将在 30 分钟的远程监督会议中通过基于家庭的 tDCS 设备接受左侧背外侧前额叶皮层的每日主动刺激 (2 mA),持续 4 周。
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基于国际 10-10 脑电图系统,2 毫安阳极刺激将应用于 F3 电极上方的左前额叶皮层。
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假比较器:假 tDCS
该小组将在 30 分钟的远程监督会议中通过基于家庭的 tDCS 设备每天接受对左侧背外侧前额叶皮层的假刺激,持续 4 周。
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假刺激将应用于 F3 电极上方的左前额叶皮层。
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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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Inhibitory Control
大体时间:Baseline
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Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention).
The performance is quantified as the ratio of correct responses to all responses.
For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
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Baseline
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Inhibitory Control
大体时间:Posttreatment (1 month follow-up)
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Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline.
The performance is quantified as the ratio of correct responses to all responses.
For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
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Posttreatment (1 month follow-up)
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Processing Speed
大体时间:Baseline
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Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention)
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Baseline
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Processing Speed
大体时间:Posttreatment (1 month follow-up)
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Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.
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Posttreatment (1 month follow-up)
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EEG P300 Event-related Potential
大体时间:Baseline
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EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention).
EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics.
While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.
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Baseline
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EEG P300 Event-related Potential
大体时间:Posttreatment (1 month follow-up)
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EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.
EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics.
While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.
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Posttreatment (1 month follow-up)
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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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Cognitive Flexibility
大体时间:Baseline
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Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting.
Participants match target stimuli based on changing rules (e.g., color or shape).
Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.
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Baseline
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Cognitive Flexibility
大体时间:Posttreatment (1 month follow-up)
|
Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting.
Participants match target stimuli based on changing rules (e.g., color or shape).
Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.
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Posttreatment (1 month follow-up)
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Working Memory
大体时间:Baseline
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Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order.
The task requires temporary storage and manipulation of information across increasing list lengths.
Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.
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Baseline
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Working Memory
大体时间:Posttreatment (1 month follow-up)
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Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order.
The task requires temporary storage and manipulation of information across increasing list lengths.
Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.
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Posttreatment (1 month follow-up)
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Episodic Memory
大体时间:Baseline
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Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures.
The task assesses the ability to encode, store, and retrieve sequential information.
Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.
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Baseline
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Episodic Memory
大体时间:Posttreatment (1 month follow-up)
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Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures.
The task assesses the ability to encode, store, and retrieve sequential information.
Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.
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Posttreatment (1 month follow-up)
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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。
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)
2022年6月7日
初级完成 (实际的)
2025年3月13日
研究完成 (估计的)
2026年9月15日
研究注册日期
首次提交
2021年10月21日
首先提交符合 QC 标准的
2021年10月21日
首次发布 (实际的)
2021年10月25日
研究记录更新
最后更新发布 (实际的)
2026年7月17日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6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.