幻听模型
研究概览
详细说明
幻觉是没有刺激的知觉。 70% 的精神分裂症患者遭受痛苦的幻听。 他们的存在会增加自杀的风险。 大多数在坚持 1 年后通过 D2 多巴胺受体阻滞剂达到缓解。 然而,30% 的患者有顽固性幻觉,50% 的患者不依从药物治疗,通常是因为不利的副作用——那些顽固和不依从的患者继续受苦。 显然需要对幻觉的机械理解作为合理治疗设计的前奏。
本研究为开发基于计算神经科学的临床幻觉介入生物标志物提供了初步步骤。
计算精神病学涉及利用计算神经科学的力量来解决患有严重精神疾病的人的临床需求。 人们对这种方法的前景进行了很多讨论。 到目前为止,研究很少,它们主要涉及功能神经影像学等相关方法。 本研究将通过使用经颅磁刺激 (TMS) 在精神病患者中因果操纵计算模型参数的神经位点来解决这一缺点,跟踪这种操纵对行为任务表现的影响。 通过这种因果干预,模型对幻觉解释的准确性将得到验证或否定。 如果得到验证,该模型可以进一步开发为预测幻觉发作、指导、开发或跟踪幻觉治疗效果的生物标志物。 如果未得到证实,则应丢弃该模型并寻求其他替代方案。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ramone Brown, BA
- 电话号码:203 974 7866
- 邮箱:belieflab@yale.edu
学习地点
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Connecticut
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New Haven、Connecticut、美国、06519
- Connecticut Mental Health Center (CMHC)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 18 - 45 岁
- 声音听力患者
- 符合 DSM-V 精神分裂症或精神分裂症样障碍的诊断标准
- 每天至少报告一次听到声音
- PANSS P3 得分 > 3(幻觉项目)
排除标准:
- 过去 6 个月内的 DSM-V 物质使用障碍
- 既往头部受过神经系统症状和/或失去知觉
- 智力障碍(IQ < 70)
- 非英语人士
TMS 的禁忌症,包括:
- 癫痫发作史
- 金属植入物
- 起搏器
- 怀孕
- 精神药物的稳定剂量少于 6 周
- 共病情绪或焦虑诊断
- 临床/行为不稳定,无法配合 TMS 程序
- 具有临床意义的医疗状况
- 基于心电图、病史、身体检查和常规实验室工作的不稳定医疗状况
- 个人中风史
- 癫痫家族史
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 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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有源比较器:TMS 到岛叶
这项研究将招募 30 名临床语音听众 (P+H+)。 他们将分两次完成两种平行形式的条件性幻觉任务(使用不同的视觉和听觉刺激),间隔一周。 TMS 和假货将以随机平衡的顺序交付。 假设:抑制脑岛会减少先前的超重。 如果这种计算扰动是条件性幻觉的原因,那么用增加脑岛参与的 TMS 改善它会减少条件性幻觉反应。 此外,与假相比,主动 TMS 后先前的加权参数将减少。 |
经颅磁刺激 (TMS) 是一种非侵入性脑刺激形式,其中使用变化的磁场通过电磁感应在大脑的特定区域产生电流。
电脉冲发生器或刺激器连接到磁性线圈,而磁性线圈又连接到头皮。
刺激器在线圈内产生变化的电流,从而感应出磁场;然后,该场会在大脑内部引起反向电荷的第二次感应。
其他名称:
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有源比较器:TMS 到小脑
这项研究将招募另外 70 名临床语音听众。
同样,他们将两次完成平行形式的条件性幻觉任务,间隔一周。
他们将在小脑上接受兴奋性 TMS(在其他情况下,以随机平衡顺序进行假)。
假设:兴奋小脑会增加信念更新。
如果较差的信念更新导致条件性幻觉,那么与假 TMS 相比,增加小脑参与应该会减少条件性幻觉并改变信念更新模型参数。
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经颅磁刺激 (TMS) 是一种非侵入性脑刺激形式,其中使用变化的磁场通过电磁感应在大脑的特定区域产生电流。
电脉冲发生器或刺激器连接到磁性线圈,而磁性线圈又连接到头皮。
刺激器在线圈内产生变化的电流,从而感应出磁场;然后,该场会在大脑内部引起反向电荷的第二次感应。
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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条件性幻觉任务表现
大体时间:大约13个月
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主要结果指标是参与者报告听到未呈现的音调的次数。
共有 360 次试验。
有 120 次无音试验。
听到声音的人通常报告在 30% 的无音调试验中听到声音(大约 36 次,而听不到声音的人为 12 次)。
与假手术相比,研究人员预计在活跃的 TMS 条件下条件性幻觉较少(少于 36 次音调报告,但没有出现)。
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大约13个月
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合作者和调查者
调查人员
- 首席研究员:Philip R Corlett, PhD、Yale School of Medicine
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
经颅磁刺激 (TMS)的临床试验
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Mayo ClinicNational Institute of Mental Health (NIMH)招聘中