CN107613860B - 脑神经活动监测 - Google Patents

脑神经活动监测 Download PDF

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CN107613860B
CN107613860B CN201680030933.2A CN201680030933A CN107613860B CN 107613860 B CN107613860 B CN 107613860B CN 201680030933 A CN201680030933 A CN 201680030933A CN 107613860 B CN107613860 B CN 107613860B
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约翰·路易斯·帕克
格里特·爱德华·格梅尔
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Abstract

监测脑神经活动包括：反复施加电刺激以在脑中引起神经反应。记录所述刺激引起的神经反应。评估所记录的神经反应随时间推移的变化的特征，以监测由所述电刺激以外的来源产生的局部场电位对所述神经反应的时变效应。

Description

脑神经活动监测
相关申请的交叉引用
本申请要求于2015年5月31日提交的澳大利亚临时专利申请号2015902022的权益，其通过援引并入本文。
技术领域
本发明涉及一种脑内神经调节，具体涉及一种方法，所述方法用于监测由电刺激引起的脑内神经反应并且用于随时间推移反复监测这样的记录以便检测或监测由其他源产生的局部场电位。
背景技术
神经调节涉及将电刺激施加到生物组织上以便引起复合动作电位(ECAP)从而产生治疗效果。神经调节可以是非侵入性的，诸如通过经皮神经电刺激(TENS)、经颅磁刺激(TMS)；或当需要植入一个或多个电极并控制刺激器时是高度侵入性的，如在脑深部刺激(DBS)的情况下。DBS已经成为对晚期帕金森病的最有效的治疗，但是是一种高度侵入性的疗法：需要将一根或多根引线深深植入小脑皮层下核并连接到胸部中植入的一个或多个脉冲发生器上。许多DBS电极靶结构已经被研究用于治疗多种多样的疾病，并且所述电极的优选位置取决于正治疗的疾病。在帕金森病的情况下，优选的靶是苍白球(GPi)的内段和丘脑底核(STN)。对于亨廷顿病和抽动秽语综合征，也以Gpi为靶，对于慢性抑郁和酒精依赖，以伏隔核为靶，并且对于阿尔茨海默病，以穹隆、下丘脑、以及Meynert基底核为靶。
帕金森病是一种影响黑质中的多巴胺释放细胞的退行性疾病。已经提出了许多描述基底神经节的功能以及这种退变与帕金森病如何相关的理论，然而，所有这类理论在描述帕金森病的所有方面具有明显不足，并且理解DBS机制仍是大量研究工作的焦点。
本说明书中已经包括的文献、行动、材料、装置、物品等等的任何讨论唯一地用于提供本发明的背景的目的。不应因为它在本申请的每项权利要求的优先权日之前存在就被看作是承认任何或所有这些事项形成现有技术基础的一部分或任何或是与本发明相关的领域中的公知常识。
贯穿本说明书，“包括(comprise)”一词或变化形式(例如“包括(comprises)”或“包括(comprising)”)应被理解为意指包括所陈述的要素、整体或步骤、或者要素、整体或步骤的群组，但不排除任何其他要素、整体或步骤、或者要素、整体或步骤的群组。
在本说明书中，要素可以是“选项清单中的至少一项”的陈述应被理解为要素可以是所列出的选项中的任何一项，或者可以是所列出的选项中的两项或更多项的任意组合。
发明内容
根据第一方面，本发明提供了一种用于监测脑神经活动的方法，所述方法包括：
反复施加电刺激以在脑中引起神经反应；
记录所述刺激引起的神经反应；
评估所记录的神经反应随时间推移的变化的特征，以监测由所述电刺激以外的来源产生的局部场电位对所述神经反应的时变效应。
根据本发明的第二方面，提供了一种脑神经刺激器装置，所述脑神经刺激器装置包括：
至少一个刺激电极，所述刺激电极被配置成有待定位在脑中并且用于向脑递送电刺激；
至少一个感测电极，所述感测电极被配置成有待定位在脑中并且用于感测所述刺激引起的神经反应；
脉冲发生器，所述脉冲发生器被配置成用于将来自至少一个刺激电极的电刺激施加至脑；
测量电路，所述测量电路被配置成用于记录所述至少一个感测电极感测到的、响应于所述电刺激的脑神经反应；以及
处理器，所述处理器用于评估所记录的神经反应随时间推移的变化的特征，以监测所述电刺激以外的来源产生的局部场电位对所述神经反应的时变效应。
本发明还提供了一种计算机软件、或包括计算机程序代码工具的计算机程序产品、或非瞬态计算机可读介质、或在所述软件或产品的控制下运行的计算机装置，其被配置成用于反复施加电刺激以在脑中引起神经反应，并且进一步被配置成用于记录所述刺激引起的神经反应，并且进一步被配置成用于评估所记录的神经反应随时间推移的变化的特征，以监测由所述电刺激以外的来源产生的局部场电位对所述神经反应的时变效应。
所述神经刺激器可以包括脑深部刺激器。
评估所记录的神经反应的变化的特征可以包括评估所观察到的神经反应的振幅。可以在频域中对所观察到的神经反应进行评估。在0.6Hz至3Hz的范围内产生的振幅变化可以使得能够评估受试者的心跳。这样的实施例认识到：心跳机械地或流变学地影响记录电极处的局部场电位，从而将调节或波动引到所观察导的ECAP振幅上。
所观察到的、引起的ECAP的振幅波动(又被称为β频带振荡)在7-35Hz的范围内可以指示帕金森患者的OFF状态，或在50-1000Hz的范围内可以指示帕金森患者的ON状态。频谱分析可以使一些实施例能够同时评估来自除了神经刺激器以外的来源的每个这样的神经活动信号。
因此应理解的是：由除了电刺激以外的来源产生的局部场电位旨在包括以机械、流变学、神经学等等方式产生的局部场电位变化。特别是在β频带振荡的情况下，应注意神经刺激器所施加的刺激可能影响改变了这样的β频带振荡的疗法，尽管对这样的机制是知之甚少的。因此，应注意局部引起的神经反应或直接由刺激产生的ECAP与β频带振荡的单独贡献之间的区别，所述频带振荡随时间推移调节一系列这样的ECAP的振幅或频谱内容。β频带振荡的单独贡献应被理解为构成除所述电刺激以外的来源并且因此属于本发明的一些实施例的范围。
根据本申请人的国际专利申请公开号WO2012/155183的教导优选地获得神经测量，其内容通过援引并入本文。
在监测由除了所述电刺激以外的一个或多个来源产生的局部场电位的时变效应时，本发明的一些实施例可以提供诊断方法。可以将由其他来源产生的神经反应效果的存在、振幅、形态、和/或潜伏期与健康的范围进行比较和/或监测其随时间推移的变化以便诊断疾病状态。本发明的方法可以应用于一些实施例中以便确定刺激的治疗效果、确定药物的治疗效果、和/或监测疾病状态。随后，可以基于诊断来请求、下定、和/或施予治疗反应。
附图说明
现在将参照附图对本发明的实例进行描述，在附图中：
图1展示了植入的脑深部刺激器；
图2是植入的神经刺激器的框图；
图3是展示了植入的刺激器与脑组织的相互作用的示意图；
图4展示了在时域中两个单独的记录信道上、一个患者中的引起的反应振幅的动态；
图5展示了对ECAP振幅的动态的频域分析；
图6展示了在STN中所观察的ECAP的频谱；并且
图7a示出了ECG频谱，并且图7b示出了ECAP频谱，展示了在ECAP频谱中心跳的存在。
具体实施方式
图1示意性地展示了植入的脑深部刺激器100。刺激器100包括被植入在患者胸部内的适合位置处的电子模块110、以及被植入脑内并且通过适合的引线连接到模块110上的两个电极组件150、152。植入的神经装置100的工作的许多方面可由外部控制装置(未示出)重新配置。而且，植入的神经装置100起到数据收集的作用，其中所收集的数据被传递到外部装置。
图2是植入的神经刺激器100的框图。模块110包括电池112和遥测模块114。在本发明的实施例中，遥测模块114可以使用任何合适类型的经皮通信190，诸如红外(IR)传输、电磁传输、电容传输和电感传输，以在外部装置与电子模块110之间传输功率和/或数据。
模块控制器116具有存储患者设置120、控制程序122等等的相关联存储器118。控制器116控制脉冲发生器124根据患者设置120和控制程序122产生电流脉冲形式的刺激。电极选择模块126将所产生的脉冲切换到电极阵列150和152中的适当电极，以将电流脉冲递送到所选电极周围的组织。测量电路128被配置为捕获在电极选择模块126在电极阵列中选择的感测电极处感测到的神经反应的测量值。
图3是展示了植入的刺激器100的电极阵列150与神经组织180(在此情况下为丘脑底核)的相互作用的示意图，然而，替代性的实施例可以被定位成邻近任何适合的脑结构。阵列152未在图3中示出，但以相同的方式在对侧大脑半球中工作。电极选择模块126选择电极阵列150中的刺激电极2来将电流脉冲递送到周围神经组织180，并且还选择阵列150中的返回电极4用于刺激电流恢复以保持零净电荷转移。
将适当的刺激递送到神经组织180引起包括复合动作电位的神经反应，所述复合动作电位将沿着相关联神经路径传播以用于治疗目的。
装置100进一步被配置成用于感测在神经组织180内传播的复合动作电位(CAP)的存在和强度，无论这样的CAP是否由来自电极2和4的刺激引起、还是以其他方式例如被阵列152中的对侧电极引起。为此，阵列150中的任何电极可以由电极选择模块126选择以用作测量电极6和测量参考电极8。测量电极6和8感测的信号被传送到测量电路128，所述测量电路例如可以根据本申请人的国际专利申请公开号WO2012155183的教导工作，所述专利申请的内容通过援引并入本文。
本发明认识到：根据所述刺激测量的所记录的神经反应可以提供大量关于正被刺激的神经元及其特征的信息。这种信息不仅在选择刺激的参数方面、而且在监测疾病过程方面可以起到至关重要的作用。复合动作电位的形状直接与电生理学和在所述动作电位演变的时间过程期间的离子信道传导性相关。所述形状反映了基础离子信道行为，这进而反映基础疾病状态。
本发明认识到：太多原因可以改变组织对刺激的反应，包括：适应、与心跳相符的电极微环境的变化、疾病状态的恶化、药物服用过程、患者当前的总体状态(睡眠、休息、运动等)。此外，可以使用ECAP来分析这类其他神经活动源的动态。
帕金森病通常与β频带振荡的增大相关联，所述频带振荡可能受到脑深部刺激影响。已经表明所引起的复合动作电位(ECAP)的测量值可以用于通过观察ECAP振幅的调节来分析脑中的信号的频谱。
所观察的调节直接反映脑中的慢振荡并且反馈***可以被设计为借助于ECAP振幅实时地刺激并记录慢波。所述反馈可以被调整成用于优化刺激参数以使某些频带(例如针对帕金森病的β频带)最小化或最大化。
ECAP特征的频率分析还可以用于从患者提取其他生理学信息(像心跳)，所述信息可以有助于在疾病过程中提供关于患者状态的更完整的图像。图4和图5给出了可以通过本发明的实施例观察的动态变化的实例。
图4展示了在时域中两个单独的记录信道上、一个患者的|N1-P2|振幅的动态。图5示出了患者之一的|N1-P2|振幅的动态的频率分析。
心跳引起的ECAP振幅的波动例如可以通过反馈进行控制，以使所引起的反应振幅在每个心动整个周期内保持恒定、或保持在所希望的轨迹上。此外或替代性地，药物引起的神经兴奋性的波动或因此ECAP振幅的波动可以通过反馈进行控制，以使所引起的反应振幅在每次给药(如用于帕金森病的左旋多巴)过程中保持恒定、或保持在希望的轨迹上。
因此，通过慢电位来调节ECAP振幅，使得ECAP振幅测量值成为对所观察的频率分量中的至少一些频率分量的替代测量。在STN中，焦点被引导向β频带振荡；在VIM中，考虑到了震颤频率。
图6是在患者1的右STN中、如使用电极R1/R2上的双极、双相刺激在电极R4上测量的4个不同刺激电流振幅的前1000个连续刺激(总测量时间为7.7秒)的频率分量的绘图。在图6中看到的类型的β范围中的低频尖峰是在所评估的五位STN患者中的几乎每一位患者中被观察到，但每个峰的位置患者与患者之间不同并且随着刺激振幅的增大不能观察到净增大或净减小。例如，在图6中的患者1中，观察到了峰在1.156Hz处。下一个峰出现在大致7Hz处，并且接着以7Hz的间隔出现周期性峰，并且另一个峰在大约18Hz处。所述峰横夸整个核而变化。所述峰的周期性表明大多数较高的频率峰是具有相同基础的谐波。这表明在这个患者中，信号中在大约1Hz、7Hz以及18Hz处存在振荡行为。
由记录电极感测的局部场电位(LFP)是在电极周围的组织中的所有电活动的总和。因此，这种活动对所观察的ECAP振幅具有调节效应。相位振幅耦合和脉冲抑制是用LFP来调节神经兴奋性的两个已知方面。如在图7a和图7b中示出的，频谱中的最小峰通过患者3中的同时ECG和ECAP测量值与心跳关联。具体地，图7a的ECG频谱示出了在1.557Hz处的心跳贡献(大致93次心跳/分钟)，密切对应于并且因此确认了在图7b的ECAP频谱中看到的在1.56Hz处的峰的来源。更详细地，图7b示出了患者3中在脉冲宽度为90μs并且和频率为130Hz的2.5mA刺激下电极R4(右)上的ECAP振幅的频谱。应注意，患者3是在受到大的测量伪影(导致了明显的指数频谱曲线)的圣保罗(Sao Paulo)试验中评估的，但是尽管如此，在1.56Hz处的峰出现在图7b的明显伪影的上方，从而支持从所述ECAP频谱中来观察心跳。
在图6中在7Hz和18Hz处的其他峰的原点目前是未知的，但是尽管如此它们仍呈现了生物标记，所述生物标记可以随时间推移被跟踪并且通过所述生物标记可以评估疾病进展或其他生物学变化。如通过LFP所测量的，在β范围(8-35Hz)内的振荡已经被提出作为帕金森病的生物标记，并且已经提出了这种振荡的破坏作为DBS的治疗有效性标记。β频带振荡似乎通过DBS治疗在PD和症状缓解中起作用，但是它们无法解释为何左旋多巴(使用最广泛的抗帕金森药物)和DBS虽然具有相似的临床效果但没有以相似的方式影响β频带振荡。本发明的实施例提供了一种手段，其中，可以有效地观察给定疗法对这种振荡的影响。
因此，已经表明ECAP振幅通过慢振荡中的至少一些慢振荡(包括心跳)进行调节，并且可以被用作测量这些频率分量的替代项。因此，本发明的一些实施例可以在植入物中实现频率分析能力，其中储存和处理受到限制。通过存储每次发射时的ECAP振幅，可以恢复最高达刺激频率的一半(奈奎斯特频率)的频率的慢振荡，只要它们调节局部场电位以及因此所观察到的ECAP即可。
因此，本发明的一些实施例可以提供一种手段，其中，一种可植入式神经刺激器可以检测由次级来源产生的神经活动，而不需要提供任何附加传感器(如EEG、EMG或ECoG传感器等等)并且甚至不需要中断治疗性电刺激。这些观察结果可以进而用于确定刺激的治疗效果、确定药物的治疗效果、和/或监测疾病状态。随后，可以基于诊断，来指示、订制、请求、和/或施予治疗性反应。
本领域技术人员应理解，在不偏离广泛描述的本发明的精神或范围的情况下，可以对如具体实施例所示的发明做出众多的变化和/或修改。因此，现有的这些实施例在所有方面都被认为是说明性的而非限制性或约束性的。

Claims (14)

1.一种脑神经刺激器装置，包括：
至少一个刺激电极，所述刺激电极被配置成有待定位在脑中并且用于向脑递送电刺激；
至少一个感测电极，所述感测电极被配置成有待定位在脑中并且用于感测所述刺激引起的复合动作电位；
脉冲发生器，所述脉冲发生器被配置成用于将来自至少一个刺激电极的电刺激施加至脑；
测量电路，所述测量电路被配置成用于记录所述至少一个感测电极感测到的、响应于所述电刺激的脑的所引起的复合动作电位；以及
处理器，所述处理器用于评估所记录的所引起的复合动作电位随时间推移的变化的特征，以监测所引起的复合动作电位上的局部场电位的时变效应，所述局部场电位由所述电刺激以外的来源产生。
2.如权利要求1所述的脑神经刺激器装置，其中，所述处理器被配置为评估所观察到的所引起的复合动作电位的振幅以评估所记录的所引起的复合动作电位。
3.如权利要求1所述的脑神经刺激器装置，其中，所述处理器被配置为评估所观察到的所引起的复合动作电位的频谱内容以评估所记录的所引起的复合动作电位。
4.如权利要求3所述的脑神经刺激器装置，其中，所述处理器还被配置为评估在0.6Hz至3Hz的范围内产生的振幅变化。
5.如权利要求3或4所述的脑神经刺激器装置，其中，所述处理器还被配置为评估在7-35Hz的β频带振荡范围内产生的振幅变化。
6.如权利要求1至4中任一项所述的脑神经刺激器装置，其中，所述处理器还被配置为将所述时变效应与健康范围进行比较和/或监测所述时变效应随时间推移的变化。
7.如权利要求5所述的脑神经刺激器装置，其中，所述处理器还被配置为将所述时变效应与健康范围进行比较和/或监测所述时变效应随时间推移的变化。
8.一种非瞬态计算机可读介质，所述非瞬态计算机可读介质包括用于监测脑神经活动的计算机程序代码工具，所述计算机代码工具在由计算装置执行时使得所述计算装置用于：
反复施加电刺激以在脑中引起复合动作电位；
记录所述刺激引起的复合动作电位；并且
评估所记录的所引起的复合动作电位随时间推移的变化的特征，以监测所引起的复合动作电位上的局部场电位的时变效应，所述局部场电位由所述电刺激以外的来源产生。
9.如权利要求8所述的非瞬态计算机可读介质，其中，评估所记录的所引起的复合动作电位包括评估所观察到的所引起的复合动作电位的振幅。
10.如权利要求8所述的非瞬态计算机可读介质，其中，评估所记录的所引起的复合动作电位包括评估所观察到的所引起的复合动作电位的频谱内容。
11.如权利要求10所述的非瞬态计算机可读介质，其中，所述计算机代码工具在由所述计算装置执行时还使得所述计算装置用于评估在0.6Hz至3Hz的范围内产生的振幅变化。
12.如权利要求10或11所述的非瞬态计算机可读介质，其中，所述计算机代码工具在由所述计算装置执行时还使得所述计算装置用于评估在7-35Hz的β频带振荡范围内产生的振幅变化。
13.如权利要求8至11中任一项所述的非瞬态计算机可读介质，其中，所述计算机代码工具在由所述计算装置执行时还使得所述计算装置用于将所述时变效应与健康范围进行比较和/或监测所述时变效应随时间推移的变化。
14.如权利要求12所述的非瞬态计算机可读介质，其中，所述计算机代码工具在由所述计算装置执行时还使得所述计算装置用于将所述时变效应与健康范围进行比较和/或监测所述时变效应随时间推移的变化。
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