神经炎症因子和外部刺激的磁共振分析 (MANIFEST)
2026年7月13日 更新者：University of New Mexico
神经炎症因子和外部刺激的磁共振分析（明显）
这项临床试验的目的是测试使用磁场的快速门诊大脑刺激（称为加速间歇性theta爆发刺激（ITB））是否可以治疗长期相互兴趣的脑部雾，抑郁症和焦虑等症状。 它旨在回答的主要问题是：
- ITB有效且可用于减少长期互联症状吗？ 我们将使用症状负担问卷调查这些症状。
- 与ITB的治疗相关的炎症性脑化学物质会发生变化吗？ 我们将研究大脑中的胆碱水平，这被认为与炎症有关。
研究人员将比较ITB的假手术与主动形式，以查看活动组的症状是否有更大的改善。
参与者将在开始，中和结束时完成症状调查，认知测试以及磁共振成像扫描。
研究概览
详细说明
COVID-19（神经PASC）急性后遗症的慢性神经精神症状可导致残疾，功能丧失和生活质量降低，但目前尚无验证的有效治疗方法。
我们提出了一项“神经炎症因子和外部刺激的磁共振分析（明显）”的随机假对照试验。
我们将向每个参与者的大脑目标提供主动或假的ITB（5倍/天，10天，25个盲人会话，然后是25个开放标签的会话）。
我们将评估从基线到治疗结束的神经PASC症状，情绪，焦虑，认知和生活质量。
我们将将症状改善与临床和成像变量相关联。
研究类型
介入性
注册 (估计的)
60
阶段
- 阶段2
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：Crystal Garcia
- 电话号码：505-272-9552
- 邮箱：crabaca@salud.unm.edu
学习地点
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New Mexico
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Albuquerque、New Mexico、美国、87106
- 招聘中
- University of New Mexico Health Science Center
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首席研究员：
- Davin Quinn, MD
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接触：
- Crystal Garcia
- 电话号码：505-272-9552
- 邮箱：crabaca@salud.unm.edu
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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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 18-80岁
- 在NIH恢复症状清单上得分为12
- 具有“脑雾”或认知困难作为正在进行的症状之一
- 流利的英语
- 如果服用精神药物，过去一个月一直处于稳定剂量。
排除标准：
- 其他神经系统疾病或任何癫痫病史的先前史，以减少加剧癫痫或其他神经系统症状的风险；
- 精神病患者（例如精神分裂症或躁郁症）的病史，以降低精神病的风险
- 持续的物质/酒精依赖的历史，以减少对诊断和脑成像的混杂影响
- 存在任何植入电气设备（例如起搏器），以降低RTMS设备故障的风险
- 最近的医疗住院（四周之内），以降低研究期间的医疗失代偿性风险
- 任何将阻止受试者完成协议的条件
- 任命法律代表，以避免胁迫脆弱的人口
- 与医学诊断或残疾有关的任何正在进行的诉讼，以防止干扰法律程序
- MRI的任何禁忌症
- 在包括未成年人，孕妇和囚犯在内的弱势群体中的成员资格，以防止强迫。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：假加速ITB
使用与主动刺激相同的线圈进行假刺激，产生同等的声音，但是它被屏蔽，因此没有有效的磁场到达参与者的大脑。
对于活跃与假状态的盲人参与者，一种没有脑部效应的轻度电刺激与头皮上的ITB同时传递给了活跃的和假手术组，从而在两组中都产生了相同的皮肤感觉。
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间歇性theta爆发刺激（ITB）是一种非侵袭性神经调节的形式，可以减轻使用DMR检测到的丘脑的神经精神症状，并通过DMR检测到丘脑的炎症，这表明使用具有可预定量化的病理生理学成分的潜在有效和有效的治疗方法。
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实验性的：主动加速ITB
在假对照阶段，将分配参与者，以接收fMRI引导的ITB（5天，每天5个会话/天）。
邀请每个参与者参加25个会话（5天）的开放标签，无盲的主动加速fMRI引导ITB到左DLPFC。
|
间歇性theta爆发刺激（ITB）是一种非侵袭性神经调节的形式，可以减轻使用DMR检测到的丘脑的神经精神症状，并通过DMR检测到丘脑的炎症，这表明使用具有可预定量化的病理生理学成分的潜在有效和有效的治疗方法。
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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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目标2
大体时间：从基线到2周的治疗结束
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确定与明显结果相关的神经代谢和结构特征。
使用DMR测量的丘脑中的ADCCHO。
胆碱（ADCCHO）的明显扩散系数是小胶质细胞活性的量度，较高的值表明较高水平的小胶质细胞。
ADCCHO减少意味着小胶质细胞的激活和炎症较少。
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从基线到2周的治疗结束
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目标1
大体时间：从基线到2周的治疗结束
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证明加速ITB是有效的，可用于减少神经PASC症状。
PACS的“认知功能/脑雾症状”评分中的分数变化：急性后Covid-19综合征问卷，与更高的分数相比，低分的得分更为严重。
比例尺1-severly无法进行4-able。
较高的分数显示出症状的改善。
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从基线到2周的治疗结束
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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。
调查人员
- 首席研究员：Davin Quinn, MD、University of New Mexico
出版物和有用的链接
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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)
2025年7月7日
初级完成 (估计的)
2029年6月30日
研究完成 (估计的)
2029年6月30日
研究注册日期
首次提交
2025年4月2日
首先提交符合 QC 标准的
2025年4月15日
首次发布 (实际的)
2025年4月23日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年7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
- 24-470
- HT9425-24-1-0742 (其他赠款/资助编号：Department of Defense)
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
人口统计学，症状，认知测试和成像数据。
IPD 共享支持信息类型
- 研究方案
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
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