高清经颅电刺激神经调节对焦虑症的治疗作用
高清经颅电刺激 (HD-tES) 是一种非侵入性脑神经调节技术,可向头皮施加小电流,以改变神经兴奋性并刺激局部大脑激活。 之前的临床试验已经探索了使用 HD-tES 治疗抑郁、焦虑、强迫症和创伤后应激障碍等心理健康状况。 该试验旨在研究 HD-tES 在改善广泛性焦虑症 (GAD) 患者焦虑症状方面的有效性和安全性,从而验证其作为焦虑症治疗的潜力。
参与者将被随机分配到四个 HD-tES 治疗组之一:(1) 将 HD-tES 抑制波形 (cDC+cTBS) 应用于右侧背外侧前额叶皮层 (DLPFC) 10 分钟,然后施加假兴奋波形 (aDC+) iTBS)刺激左侧 DLPFC 10 分钟。 (2)对右侧DLPFC施加假抑制波形(cDC+cTBS)刺激10分钟,然后对左侧DLPFC施加HD-tES兴奋波形(aDC+iTBS)10分钟。 (3)将HD-tES抑制波形(cDC+cTBS)施加到右侧DLPFC 10分钟,随后将HD-tES兴奋波形(aDC+iTBS)施加到左侧DLPFC 10分钟。 (4)对右侧DLPFC施加假抑制波形(cDC+cTBS)刺激10分钟,然后对左侧DLPFC施加假兴奋波形(aDC+iTBS)刺激10分钟。 无论小组分配如何,参与者都将接受为期两周的治疗课程,每周五次,每天不超过一次。 每节课持续约 20 分钟。 将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Yi Jing Huang
- 电话号码:+886 2-33668166
- 邮箱:yijinghuang@ntu.edu.tw
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 年龄在 18 岁至 65 岁之间。
- 精神科医生根据 DSM-5 标准诊断患有广泛性焦虑症 (GAD)。
- 汉密尔顿焦虑评定量表(HAM-A)评分≥14。
- 汉密尔顿抑郁量表(HAM-D;17 项版本)得分 ≤ 17。
- 入组前至少6周持续接受心理咨询和/或稳定种类和剂量的药物治疗;或被认为不适合接受药物治疗和/或心理咨询;或拒绝药物治疗和/或心理咨询。
排除标准:
- 在研究前 2 周内和研究期间接受过 rTMS 或任何其他形式的非侵入性脑刺激技术。
- 存在严重的神经系统疾病(例如中风、脑肿瘤、癫痫、器质性脑疾病)或精神疾病(例如精神分裂症和其他精神障碍、双相情感障碍、强迫症、其他类型的焦虑症、药物滥用)。
- 可能影响自主神经或中枢神经系统的严重或不稳定的生理状况(例如急性胃肠道疾病、心血管疾病、甲状腺疾病)。
- 有心律失常史。
- 存在植入的医疗电子设备(例如起搏器)。
- 头部或颈部存在金属植入物。
- 电极接触部位头皮上的开放性伤口。
- 根据医生评估,有头部手术史或严重头部外伤史,使个人不适合纳入。
- 具有显着自杀风险的个人(HAM-D 第 3 项自杀风险评分≥3)。
- 存在免疫疾病(例如系统性红斑狼疮、类风湿性关节炎、强直性脊柱炎、炎症性肠病)。
- 对电刺激异常或高度敏感而无法耐受的个体。
- 怀孕(对于女性参与者:必须绝经后或手术绝育。 有生育能力的女性妊娠试验必须呈阴性。 有能力怀孕的女性参与者及其男性伴侣与有能力怀孕的女性伴侣必须同意在试验期间以及最后一次研究干预后 4 个月内使用有效的避孕措施,例如口服避孕药、双重屏障方法或宫内节育器,或同意在此期间避免性活动。 非生育女性被定义为接受双侧卵巢切除术或绝经后的女性。
- 服用降低癫痫发作阈值的药物。
- 酗酒或滥用药物。
- 凸性颅骨缺损或颅内压升高。
- 哺乳期妇女。
- 根据医生评估认为不适合经颅电刺激的其他情况。
学习计划
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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实验性的:HD-R_cDC+cTBS 和假-L_aDC+iTBS
|
将 HD-tES 抑制波形 (cDC+cTBS) 应用于右侧背外侧前额叶皮层 (DLPFC) 10 分钟,然后将假兴奋波形 (aDC+iTBS) 刺激应用于左侧 DLPFC 10 分钟。
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实验性的:假-R_cDC+cTBS & HD-L_aDC+iTBS
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对右侧 DLPFC 施加假抑制波形 (cDC+cTBS) 刺激 10 分钟,然后对左侧 DLPFC 施加 HD-tES 兴奋波形 (aDC+iTBS) 10 分钟。
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实验性的:HD-R_cDC+cTBS & HD-L_aDC+iTBS
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将 HD-tES 抑制波形 (cDC+cTBS) 应用于右侧 DLPFC 10 分钟,然后将 HD-tES 兴奋波形 (aDC+iTBS) 应用于左侧 DLPFC 10 分钟。
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假比较器:假-R_cDC+cTBS & 假-L_aDC+iTBS
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对右侧 DLPFC 施加假抑制波形 (cDC+cTBS) 刺激 10 分钟,然后对左侧 DLPFC 施加假兴奋波形 (aDC+iTBS) 刺激 10 分钟。
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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通过汉密尔顿焦虑评定量表(HAM-A)评估和干预后焦虑症状严重程度的变化
大体时间:将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
|
将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
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干预后通过状态-特质焦虑量表(STAI)评估状态和特质焦虑的变化
大体时间:将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
|
将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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干预后通过汉密尔顿抑郁量表(HAM-D)评估抑郁症状严重程度的变化
大体时间:将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
|
将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
|
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干预后根据匹兹堡睡眠质量指数 (PSQI) 评估的睡眠质量变化
大体时间:将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
|
将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
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通过视觉模拟量表(VAS)评估的自评焦虑水平
大体时间:每次干预后3分钟内(共10次,每周5次,持续2周)
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每次干预后3分钟内(共10次,每周5次,持续2周)
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NeXus-10MK Ⅱ评估心率变异性(HRV)
大体时间:每次干预后10分钟内(共10次,每周5次,持续2周)
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每次干预后10分钟内(共10次,每周5次,持续2周)
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通过副作用问卷评估的副作用
大体时间:每次干预后10分钟内(共10次,每周5次,持续2周)
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每次干预后10分钟内(共10次,每周5次,持续2周)
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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干预后通过 N-back 任务评估工作记忆能力的变化
大体时间:将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
|
将在治疗前、治疗期间每周(第一周和第二周结束时)进行评估,并在治疗结束后一周进行后续评估。
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合作者和调查者
出版物和有用的链接
一般刊物
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