CN113631219A - 改善脑功能的方法和仪器 - Google Patents
改善脑功能的方法和仪器 Download PDFInfo
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- CN113631219A CN113631219A CN202080024245.1A CN202080024245A CN113631219A CN 113631219 A CN113631219 A CN 113631219A CN 202080024245 A CN202080024245 A CN 202080024245A CN 113631219 A CN113631219 A CN 113631219A
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Abstract
本发明描述了用于改善脑功能和治疗包括阿尔茨海默病在内的老年痴呆症的非侵入性方法和治疗装置。非侵入性方式选自电刺激、热刺激、IR(红外)辐射或它们的组合。在一些实施例中,该方法和装置利用通过人体头部的针灸部位的电流刺激来实现所需的治疗效果。
Description
相关申请的交叉引用
本申请声明对于2019年3月26日提交的美国临时专利申请62/823,656和2020年3月15日提交的美国专利申请16/819,165享有优先权。在先申请公开的全部内容被认为是即时申请信息披露的一部分,而在此引用。
发明背景
痴呆症是一类广泛的脑部疾病,会导致思考和记忆能力长期逐渐下降,严重到足以影响日常功能。其他常见症状包括情绪问题、语言困难和行动下降。意识通常不受影响。痴呆症的诊断依据包括超出一个人通常心理功能的改变,并且出现比人们正常衰老造成的更大的心智功能下降。最常见的痴呆类型是阿尔茨海默病,占病例的 50% 至 70%。其他常见类型包括血管性痴呆(25%)、路易体痴呆(15%)和额颞叶痴呆。不太常见的原因包括正常压力脑积水、帕金森病痴呆、梅毒、HIV 和克雅氏病。诊断通常基于疾病史和认知测试,医学成像和血液测试用于排除其他可能的原因。小型精神状态检查是一种常用的认知测试。预防痴呆症的努力包括尝试减少高血压、吸烟、糖尿病和肥胖等风险因素。
目前还没有已知的治疗痴呆症的方法。胆碱酯酶抑制剂如多奈哌齐是经常使用的,可能对轻度至中度疾病有益。然而总体效果可能很小。有许多措施可以改善痴呆症患者及其照顾者的生活质量。认知和行为干预可能是合适的。对看护者进行教育和提供情感支持很重要。锻炼计划可能对日常生活活动有益,并可能改善结果。芳香疗法和按摩治疗效果有未确认的证据。研究支持***素在缓解痴呆症的行为和心理症状方面的有效性和安全性。来自植物或鱼类的 Omega-3 脂肪酸补充剂似乎不会对患有轻度至中度阿尔茨海默病的人有益或有害。目前尚不清楚服用 omega-3 脂肪酸补充剂是否可以改善其他类型的痴呆症。美国专利申请US20190126062A1公开了使用具有约30Hz至约50Hz,更具体地约40Hz的频率的视觉/听觉刺激来治疗有需要的受试者的痴呆或阿尔茨海默病的装置、***和方法,非侵入性的传递给受试者以在受试者的多个大脑区域中诱导伽马波振荡,包括前额叶皮层(PFC) 和海马体。
发明内容
本申请公开了具有非侵入性手段的方法和设备,用于改善大脑功能,例如改善睡眠和记忆力,以及治疗包括阿尔茨海默病在内的老年痴呆症。 非侵入性方式选自电刺激、热刺激、IR(红外线)辐射或它们的组合。在一些实施例中,本发明利用通过人体头部的针灸部位的电流来实现所需的治疗效果。
在一些实施例中,本发明的装置和方法主要针对刺激选自百会(DU/GV20)、四神聪(EX-HN1)、风池(GB 20)、太阳穴(EX-HN5) 和神庭 (DU/GV 24) 中的一个或多个穴位,用于改善脑功能和治疗老年痴呆症,包括阿尔茨海默病。 优选地,本发明中的装置是便携式的并且是自包含的,具有附接到头部的装置。 它可以是帽子或头盔的形式。 该装置可以产生电脉冲或热或红外辐射或它们的组合并将它们应用于所述穴位。
一方面,本申请中描述的方法和装置使用电脉冲与热或IR辐射组合施加到头部的穴位或其他区域以实现所需的治疗效果。需要改善大脑功能的人(例如减少衰老,改善记忆和睡眠,改善血流量,减少脑功能障碍,减少认知障碍,改善脑组织生长,改善神经元/神经完整性,生长,功能,活动和功能)或治疗阿尔茨海默病或血管性痴呆等痴呆症者,将电极置于百会、四神聪、风池、神庭等穴位上,通过这些电极进行电刺激。出于相同目的,该设备产生热量和/或红外线刺激也可以应用于这些位置。这具有改善大脑功能和/或减轻痴呆症状的作用。相同的装置和方法也可用于治疗抑郁症和失眠症。脉冲发生电路和电源可以方便地封装在具有固定到头部结构的壳体结构中,例如帽子或头盔形状的结构。一个或多个电极位于与皮肤接触的壳体内表面上。放置该装置使得电极/数个电极覆盖已知会产生所需治疗效果的穴位。或者,该装置被放置到使得电极接近或覆盖穴位下方延伸的神经的区域,在这种情况下,该装置可以被放置在距相关穴位一定距离的位置以使该装置可被舒适放置。它也可以附于头部的其他区域。
该装置还可以包含一个或多个内置加热元件,可以将皮肤接触面的温度保持在40~60度之间,从而为刺激部位/区域提供加热效果。该装置还可以包含一个或多个内置的红外(IR)辐射元件,该元件可以产生光并将其传递到皮肤接触表面以向刺激部位/区域提供IR刺激效果和提供加热效果。
附图说明
图1显示了适用于该设备的电路的框图的示例。
图2显示了适用于本发明的具有附加加热元件的装置的电路框图的示例。
图3显示了适用于本发明的装置的电路图的示例。
图4显示了器件电极组件的示例。
图5显示了另一种类型的装置电极组件的示例。
图6显示了具有加热元件的装置电极组件的示例。
图7显示了具有光辐射元件的装置电极组件的示例。
图8显示了具有IR辐射和加热功能的电极组件的示例。
图9是佩戴在使用该装置的人的头上的本发明装置的示例的透视图。
图10显示了头部刺激位置的例子。
图11显示了包含电极和加热元件阵列的装置的示例。
具体实施方式
在一些实施例中,本发明的方法和装置所使用的电脉冲频率优选(但不限于)在2~100Hz之间或2~100Hz内的频率组合;优选脉冲宽度为0.001~10ms,优选电流为0.5-100毫安。在一些实施例中,示例性的优选电脉冲重复率为每秒约 2 个脉冲,脉冲宽度为 600微秒,或每秒约 15 个脉冲,脉冲宽度为 300 微秒,或每秒约 40 个脉冲(例如,30-50 或35-45个脉冲),脉冲宽度为200微秒,或大约每秒100个脉冲,脉冲宽度为200微秒,或上述波形的组合,以提供有效的结果。优选的电功率水平可以是大约0.5-50毫安峰值脉冲高度或需要的对象感到舒适的其他功率水平。在非侵入性神经刺激设备中还可以使用更广泛的脉冲模式。优选双向脉冲以避免皮肤损伤。一般来说,每天或按需进行 10-60 分钟的刺激可以为有需要的人提供有效的治疗。
在其他示例中使用中频电流。 典型的中频(例如 1~10 kHz)可以刺激肌肉并为治疗区域提供类似按摩的感觉。为了在每次去极化后中断电流,可以采用有节奏地增加和减少幅度(幅度调制)。 调幅频率 (AMF) 决定了去极化的频率。 AMF 对应于低频电疗中使用的频率。幅度调制也可以采用脉宽调制代替。
在调制中频电疗中使用的电流模式也可以在本发明的装置中使用。合适的频率可以是 2-10 kHz。可以使用低频和中频的组合,例如 1~150Hz低频电流与2~10 kHz中频电流的频率组合。 低频和/或中频可以具有多种波形/模式(例如正弦波、方波、连续波、不连续波、变化幅度、对称波或非对称波等)。中频的幅度可以在低频模式下变化。 在一些示例中,合适的电流在0.05~5mA之间。
伽马波是人类神经振荡的一种模式,频率在 25 到 100 赫兹之间,但 40 赫兹是典型的。它可以有益于和改善大脑功能。本发明可以使用能够刺激产生大脑伽马波的电频率,例如在25~100Hz之间,优选在30~60Hz之间,或者35~50Hz之间。在一些实施例中,电脉冲频率在35~45Hz之间。在一些实施例中,电脉冲频率是40Hz。在一些实施例中,频率为40Hz且峰宽在0.1~0.6ms之间,例如 0.3 毫秒。在一些实施例中,以循环批次施加电脉冲,在每个循环批次中,电流从低到高开始,然后保持恒定一定时间,例如5-10秒,然后逐渐下降到低电流以开始下一个循环批次如图所示。每个循环批次之间可有一个间隔期(无电脉冲),例如2-10 秒。也可以使用不同频率的伽马波组合,例如前5分钟频率为35赫兹,然后5分钟为40赫兹,然后5分钟为45赫兹,然后再回到40赫兹持续10分钟。
该装置还可以包含一个或多个内置加热装置,可以将皮肤接触表面的温度保持在35~60度之间,以对刺激部位/区域提供加热效果。加热装置可以是由电池供电的电加热元件。表面的加热温度优选在35~55度之间。一种优选的加热元件是自调节加热器,例如聚合物PTC加热元件或陶瓷PTC加热器。电阻加热器可以由导电 PTC 橡胶材料或陶瓷 PTC 材料制成,其中电阻率随温度升高呈指数增加。这种加热器在低温时会产生高功率,并迅速将自身加热到恒定温度。由于电阻率呈指数增加,加热器永远无法将自身加热到高于此设定温度。可以在橡胶或陶瓷的生产过程中选择温度。可以循环加热步骤以避免皮肤耐受。例如,每个加热步骤是 1-10 分钟,然后是 1-3 分钟不加热时间。
该装置还可以包含一个或多个内置的红外辐射元件,这些元件可以产生红外辐射并将其传递到皮肤接触表面,以向刺激部位/区域提供光子刺激和加热效果。红外辐射元件可以是钨丝、碳或铁、铬和铝的合金,以及 LED ,激光,或它们的组合以提供更宽的波长覆盖范围。 IR辐射元件广泛用于物理治疗并且它们可以容易地适用于本发明。该装置可以具有一个连接多个红外光纤的集中式红外辐射元件,这些光纤可以将红外辐射传输到所需的刺激部位。壳体的表面可以具有一个或多个透光窗以允许从光源发射的光子到达皮肤。 IR的合适波长在700 nm-1mm之间。它可以是 NIR 或 MIR 或 FIR 或其组合。在一些实施例中,它在800 nm~100μm之间。在一些其他例子中,它在1μm~20μm之间。红外辐射的输出功率可以调节,以确保有效和安全的辐射。优选地,合适的功率水平可以将目标皮肤部位加热到40℃~50℃并且不会灼伤/损伤皮肤并且被用户接受。辐射可以是连续的,也可以是脉冲的,如前面描述的电脉冲刺激中使用的那样。在一个例子中,使用具有2μm-10μm波长输出的10W IR辐射元件;输出耦合到红外光纤,以将红外辐射传送到治疗部位。又如,可以使用808nm GaAlAs激光器或1550nm激光器,连接多根光纤,向所需部位提供红外脉冲,在10 -1000 mW/cm2的功率水平下,发射频率为30-50 Hz的伽马波。使用 IR LED 时,每个刺激部位都可以连接自己的 IR LED,无需使用光纤。
因此,本发明公开了一种用于改善有需要的受试者的脑功能的方法,该方法包括向受试者头部的表面区域施用频率为约35Hz至约45Hz的非侵入性电刺激。 还可以对头部施加额外的热刺激。
该设备可以具有通信模块,该通信模块可以与外部控制(命令)模块通信以接收刺激输出的命令(例如刺激类型、时间、频率、开/关、功率水平和脉冲模式)以产生相应地刺激。 外部控制模块可以是安装了专用应用程序的遥控器或计算机或手机。 通信可以利用Wi-Fi 或蓝牙或 IR 或无线电信号。 该设备可以有一个开/关控制来打开或关闭通信模块。
该设备的电路可以用众所周知的技术来构建。 有许多种设计方案可以用来实现所需电路。 图1显示了一个适用于该设备的电路图的示例。 微处理器从设备上的键盘接收输入以设置刺激脉冲的强度水平,以及电流反馈以调节微处理器输出到电压转换器和电流源以在键盘设置的电流水平下产生刺激脉冲。电压转换器将电池电压转换为高电压。电流源的输出连接到接触皮肤的电极。诸如可充电电池组之类的电池为每个模块供电。图2显示了适用于具有由微处理器和电压转换器控制的附加加热元件的装置的电路图的示例。图3显示了适用于前述设备的电路图的示例。
图4显示了设备的外电极组件的一种实施方式。在装置壳体的皮肤接触面上,两个电极并排排列。一个电极将用作阴极(或连接到电流源的火线),另一个电极将用作阳极(或连接到零线)。外电极组件也可用于通过诸如线带类的连接结构与设备外壳连接以将电脉冲传送到外电极。如果设备包含多个壳体,则每个壳体可以只包含一类电极; 一些壳体中的电极用作阴极,而另一些壳体中的电极用作阳极,它们在刺激过程中可以改变极性。
图5显示了另一种类型的设备电极组件的实施例的皮肤接触表面。在装置的皮肤接触面上,附有多个小电极。一些电极用作阴极,而其他电极用作阳极。
图6显示了具有加热元件的设备电极组件的一个实施例。如图所示,在装置的皮肤接触面上,附着有两个电极。在两个电极之间是一个加热元件,或一个导热区域(例如金属片)下面附有一个加热元件。或者,加热元件或导热区域可以是阵列形式。在另一个替代方案中,导热区域也可以是电极。
图7显示了具有光辐射元件的设备电极组件的一个实施例。如图所示,在装置的皮肤接触面上,附着有两个电极。在两个电极之间是一个透明的窗口,下面连接着一个激光输出源。或者,透明窗口可以是阵列形式。激光光源通过光纤将光传送到这些窗口。
由于使用了多个刺激位点,一些电极组件可用作阴极,而另一些可用作阳极,因此不需要在一个电极组件中集成不同类型的电极(阴极或阳极)。例子如图 8所示。电极可以是阴极或阳极或交替极性。
图9是佩戴在使用该装置的人的头上的本发明装置的一个实施例的透视图。该设备的电源和脉冲产生电路可以集成在头盔或帽子状外壳7内。或者,控制、电源和/或脉冲产生电路也可以放置在与外壳7相连的且带有如图 9 所示的电线的另一个外壳8中。外壳也可以是其他形状和形式,例如头带,只要它包含将其固定在头部上的装置或提供将外壳放置在头部上的支撑的装置。图中外壳连接有外部控制单元8,具有激励功率电平控制按钮和一个LCD状态显示器。功率电平控制按钮控制电极的输出功率电平。更高的功率水平(刺激电流的强度)通常会产生更强的刺激,这可能会产生更好的治疗效果。患者使用控制按钮调节功率水平,以达到理想的治疗效果和最佳舒适度。这些按钮也可用于控制脉冲模式。LCD显示屏显示设备的工作状态,例如当前功率电平和脉冲模式。计时功能也可以集成在 LCD中。
四个电极组件 2、3、4 和 5 在壳体的内表面排列,使它们分别接触神庭、百会、后顶和风府附针灸部位的皮肤。 两个外部电极组件1和6(如图4中描述的那些)通过电线连接到壳体7以获取电,并且分别附着于太阳和印堂以提供刺激。 壳体向电极组件发出电脉冲以有需要者施加电刺激。 自粘电极可用于外部电极组件。 除了使用电线之外,还可以使用包含电线的刚性或半刚性连接结构将外部电极组件与壳体连接。
如前所述,图9中的设备还可以包含向这些针灸部位提供加热和IR辐射的装置。加热/红外刺激可以与电刺激同时应用,也可以交替或先后应用。 在一些实施例中,该装置仅包含加热或IR辐射装置而没有电刺激装置并且仅通过直接加热或IR辐射来实现治疗效果。
如图 9 所示,有需要的人将设备放在他的头上,并将电极附着在选定的穴位上,通过这些电极对这些穴位施加电刺激。加热或红外辐射刺激也可以同时或分别应用于这些部位。主要刺激点(部分见图10)选自百会、四神聪、风池、神庭、本神、上星、风府、印堂、太阳、哑门、当阳、定神、首面、承灵、脑户等穴位。可以使用一个或多个主要刺激点。优选的配穴可选自大椎、内关、三阴交、人中、神门、心俞、间使、关元、涌泉、太溪、血海、双灵、腕骨、大杼、人迎、肾俞等穴位。将辅助穴位与主要刺激点结合使用比单独使用主要穴位具有更高的有效性。此外,刺激其中一些穴位需要将电极连接在头部以外的地方(例如,需要将电极连接到手腕以刺激内关穴)。为了刺激辅助穴位,可以使用与主外壳(例如头部外壳或外部电源/电子设备)连接的外部电极以到达这些部位。每个点/区域的刺激可以基于预定义的模式(例如从左到右或从中心到***等循环)同时或顺序进行。如前所述,电刺激可以用相应的机构以加热或红外辐射代替。
或者,刺激区域不仅限于针灸部位。 只要使用者感觉舒适,它可以放置在头部的其他区域。 在一些实施例中,如图10所示的装置可以是电极阵列或具有加热/红外辐射装置的电极阵列,其覆盖大脑顶部的皮肤,刺激脉冲频率在25~100Hz之间,优选地介于 35~45赫兹。 例如,Novocure 使用的设备可以修改为提供 40Hz 频率的电刺激,以改善大脑功能和治疗老年痴呆症,包括阿尔茨海默病。 美国专利US8715203和US7805201中公开的设备可以修改为具有当前发明所需的频率。
在一个例子中,图 9 中描述的设备置于志愿者的头部,以 40Hz 的电脉冲在志愿者感觉舒适的功率水平下刺激选自印堂、神庭、白会、太阳和四神聪的针灸部位,每天约0.5小时,持续2 周。志愿者感觉记忆力、睡眠质量和认知水平得到改善。
在另一个例子中,一个装置置于志愿者的头部,以 40Hz 的电脉冲在志愿者感觉舒适的功率水平下刺激神庭、百会、太阳和四神聪,每天约 0.5 小时,持续 2 周。志愿者感觉记忆力、睡眠质量和认知水平得到改善。
在另一个例子中,一个包含电极阵列的装置被附于志愿者的头部,以在志愿者感觉舒适的功率水平下用 35-45 Hz 的电脉冲刺激非针灸部位的头部顶部表面约每天1 小时,持续2 周。志愿者感觉记忆力、睡眠质量和认知活动得到改善。
在另一个例子中,将进一步包含加热元件的装置置于志愿者的头部,以在志愿者感觉舒适的功率水平以35-45Hz的电脉冲和热刺激,刺激选自印堂、本神、后顶、风都和风池的部位,每天0.5-1 小时,持续 2 周。 志愿者感觉记忆力、睡眠质量和认知活动得到改善。
此外,具有类似于图9中的结构形状的装置,内含相应部件,向头部尤其是头部的顶部和背面提供直接加热(例如使用加热元件)和/或IR辐射,也可用于改善脑功能和/或通过改善大脑中的血流量来减轻痴呆症的症状。大脑区域的更高温度(加热)可以促进血液流动,从而改善大脑功能和/或减轻痴呆症的症状。该设备本质上是带有内置加热装置的帽子或头盔,可以覆盖头部顶部和/或后部的大部分区域,不限于先前描述的针灸部位。它可以具有绝缘层以保持覆盖区域内的高温(例如40-60度)。加热可以是恒定的或间歇的。有需要的人可以戴上它来加热他们的大脑区域,以改善大脑功能和/或减轻痴呆症的症状(例如每天 3 次,每次 0.5 小时)。加热/红外刺激可以与电刺激同时应用,可以交替或顺序先后应用。在一些实施例中,该装置仅包含加热或IR辐射装置而没有电刺激装置并且仅通过直接加热或IR辐射来实现治疗效果。该设备还可以有一个带有内置直接加热/红外辐射装置的附件,可以包裹有需要的人的脖子来加热他们脖子上的血管以促进血液流动,这本质上可以是一个内置直接加热/红外辐射元件的围脖/围巾。本发明公开了一种通过增加大脑中的血流量来改善大脑功能和/或减轻痴呆症状的方法,这是通过对有需要的人的头部和颈部施加直接加热和/或IR辐射来实现的。红外辐射刺激也可以在 35~45 Hz 的频率下施加。
适用于本发明的装置可以是许多不同的形式和形状,例如帽子,发带,眼镜,头盔的形式或自粘贴片的形式。 它们的皮肤接触部分包含一个或多个电极,可用于向有需要的对象施加电脉冲。它们可以通过蓝牙或Wi-Fi或其他射频信号与远程控制设备(例如手机)通信并由远程控制设备控制。 可以应用手机应用程序来对设备进行控制。
Claims (5)
1.一种改善有需要的受试者的脑功能的方法,该方法包括向受试者头部表面区域施用频率为35Hz至45Hz的非侵入性电刺激。
2.根据权利要求1的方法, 其中所述频率为约 40 Hz。
3.根据权利要求1的方法, 其中对头部施加额外的热刺激。
4.根据权利要求1的方法, 其中改善脑功能是治疗痴呆症。
5.根据权利要求1的方法, 其中对头部施加额外的红外辐射刺激。
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