评估 MeRT 治疗创伤后应激障碍的安全性和有效性的临床试验 (MeRT-005-B)
2026年1月14日 更新者：Wave Neuroscience
一项前瞻性、双盲、随机、假对照、临床试验，以评估生物识别引导的脑磁共振疗法 (MeRT) 治疗伴有和不伴有持续性脑震荡后症状 (PPCS) 的创伤后应激障碍的安全性和有效性创伤性脑损伤 (TBI)
本研究的目的是评估个体化、生物识别学引导的磁电子共振疗法 (MeRT) 治疗创伤后应激障碍伴或不伴持续性脑震荡后症状 (PPCS) 的安全性和有效性 (TBI) ).
研究概览
详细说明
MERT-005-B 是一项前瞻性、双盲、随机、假对照、平行组、分层、适应性临床试验，旨在评估脑电图引导的 MeRT 对患有和不患有持续性创伤后应激障碍的人的疗效。创伤性脑损伤 (TBI) 后的震荡症状 (PPCS)。
共有 152 名参与者将在测试阶段随机分配，盲法适应性样本量重新评估多达 176 名参与者，以及数据和安全监测委员会 (DSMB) 的疗效监测组序贯方法。
试验阶段已完成，随机分配了 74 名参与者。 试验阶段数据将用于确认 MeRT 的安全性。 对于测试阶段，符合条件的参与者将以 1:1 的分配比例随机分配到 MeRT 或假 MeRT 治疗组，在招募地点进行分层和两个级别的 PPCS 合并症 (+/-)。
初步资格评估和数据收集将在筛选访问 (SC) 时进行。 在 SC 访问之后，将有 5 周的治疗期，期间将在工作日每天访问研究地点期间进行主动或假调查治疗。 所有继续符合条件的参与者将获得额外 2 周的积极 MeRT 研究治疗。
主要研究结果将在 5 周治疗期结束时的第二次随访 (F2) 时收集。 将在第三个治疗周（F1 后续访问）期间进行简短的数据收集访问。 在研究治疗的第一天后 90 天 (F3) 和 180 天 (F4) 将进行额外的随访。
参与评估的参与者、临床医生和所有人员将对研究治疗组分配不知情。
该试验的第一阶段是与美国特种作战司令部 (USSOCOM) 和亨利杰克逊基金会合作进行的。
研究类型
介入性
注册 (实际的)
158
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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California
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Costa Mesa、California、美国、92626
- BrainHealth Solutions
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Long Beach、California、美国、90822
- VA Long Beach Healthcare System
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San Diego、California、美国、92103
- SoCal Neuroscience Research Unit
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North Carolina
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Raleigh、North Carolina、美国、27607
- UNC Rex Hospital
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Ohio
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Columbus、Ohio、美国、43219
- Columbus Brain Research Center
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Pennsylvania
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Bryn Mawr、Pennsylvania、美国、19010
- Center for Interventional Pain and Spine
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Texas
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Plano、Texas、美国、75093
- Texas A&M Research Center
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Washington
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Bellevue、Washington、美国、98004
- Seattle Neuropsychiatric Treatment Center (Seattle NTC)
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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：
参与者必须满足所有纳入标准才有资格参加研究：
- 愿意并能够同意参与研究
- 18 - 65 岁
- 根据 DSM-V 标准通过 CAPS-5 诊断 PTSD
- 符合 DSM-5 PTSD 症状标准的症状发作在筛选访视前持续至少 6 个月
- 最低 PCL-5 分数为 30
排除标准
如果以下一项或多项排除标准适用，则参与者将被排除在研究参与之外：
- 指数创伤发生在 16 岁之前
- 开放性颅骨损伤史
神经系统疾病史，包括但不限于：
- 癫痫症
- 任何可能与颅内压升高有关的情况
- 脑占位性病变
- 脑血管意外史
- 脑动脉瘤病史
- 在脑电图记录期间表明癫痫发作风险的脑电图异常，即异常局灶性或全身性减慢或发作尖峰
- 筛选时无法计算 EEG 固有 alpha 频率
- 在筛选访问前 3 个月内参与任何介入研究方案
- 任何类型的 ECT、rTMS 或 MeRT 治疗史
- 在筛选访视后 30 天内接受过任何抗精神病药物治疗
- 在筛选访视后 30 天内接受过任何苯二氮卓类药物或抗惊厥药物治疗
- 在筛选访视时的前 60 天内使用任何限制性伴随药物（即 NDRI、SSRI、SNRI 或 QBDZ）进行的当前治疗不稳定
- 颅内植入物（例如，动脉瘤夹、分流器、刺激器、耳蜗植入物、支架或电极）或头部内（不包括嘴）或头上任何其他无法安全移除的金属物体
- 可能受刺激器磁场影响的生物医学设备，包括那些不在头内或头上的植入式或不安全移除式设备（例如，心脏起搏器、心律转复除颤器 (ICD) 或药物分配设备）
- 具有临床意义的医学疾病或病症，包括但不限于任何不受控制的甲状腺疾病、肝、心脏、肺和肾功能障碍，或长期过量饮酒，研究者判断可能对参与者造成潜在的安全风险或限制试验结果的解释
- 怀孕或女性在试验过程中不愿使用有效的节育措施
- 计划在筛选访问后 80 天内（含）离开该地区，或知道将离开该地区
- 不愿意或不能遵守研究治疗、数据收集时间表或研究程序，或任何条件，包括无法用英语交流，研究者判断可能会阻止参与者完成研究，使研究结果无法解释，或对参与者或研究人员造成不可接受的安全风险，而该风险未在排除标准中另行列出。
- 具有临床意义的精神病理学，包括但不限于精神分裂症或双相情感障碍，或研究者判断可能对参与者造成潜在安全风险或限制试验结果解释的其他精神疾病
- 自杀或对他人施暴的风险增加
- 目前的心理治疗，预计将在整个试验过程中持续进行，在筛选访视时的前 60 天内开始
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：活性 MeRT 治疗
主动治疗将包括每分钟 6 秒，每天 30 分钟，每周 5 天，持续 5 周。
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一种个性化的生物识别指导方案，称为磁脑电图/心电图共振疗法 (MeRT) 治疗，专门针对每个参与者的脑电图内在阿尔法频率 (IAF) 量身定制。
rTMS 应用于参与者的 IAF。
其他名称：
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假比较器：假 MeRT 治疗
假治疗将包括每分钟 6 秒，每天 30 分钟，每周 5 天，持续 5 周。
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rTMS 线圈不发射磁刺激。
其他名称：
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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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PTSD 症状的变化
大体时间：五周
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通过 PTSD Checklist-5 (PCL-5) 衡量的 PTSD 症状变化。
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五周
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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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PPCS 的变化
大体时间：五周
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TBI 后患有 PPCS 的参与者子集中 Rivermead 脑震荡后症状问卷 (RPQ-16) 总严重程度评分的减少来衡量持续性脑震荡后症状的变化。
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五周
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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安全结果 - 不良事件的事件和类型
大体时间：大约3个月
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不良事件的数量和类型（AES）和严重的不良事件（SAE）
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大约3个月
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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：Kenneth Ramos, MD,PhD、Texas A&M University
- 学习椅：Adele Gilpin, PhD,JD、GilpinPhillips BIOMED, LLC
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)
2022年4月4日
初级完成 (实际的)
2025年9月18日
研究完成 (实际的)
2025年11月4日
研究注册日期
首次提交
2016年11月10日
首先提交符合 QC 标准的
2016年12月8日
首次发布 (估计的)
2016年12月13日
研究记录更新
最后更新发布 (实际的)
2026年1月15日
上次提交的符合 QC 标准的更新
2026年1月14日
最后验证
2026年1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
- MeRT-005-B
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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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