CN110339481A - 可变间隔频率的磁刺激设备及方法 - Google Patents

可变间隔频率的磁刺激设备及方法 Download PDF

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CN110339481A
CN110339481A CN201910269576.0A CN201910269576A CN110339481A CN 110339481 A CN110339481 A CN 110339481A CN 201910269576 A CN201910269576 A CN 201910269576A CN 110339481 A CN110339481 A CN 110339481A
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何康威
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Vanitas Research Center Co Ltd
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Abstract

本发明提供一种用以调整哺乳类动物脑内活动的方法，将哺乳类动物置于连续经颅磁刺激(rTMS)仪，受到可变脉冲间隔的电磁刺激，治疗时间应足以调整脑内活动，藉以达到改善内科状况或临床状况。治疗条件不受限于创伤后症候群(PTSD)，自闭症谱系障碍(ASD)以及阿兹海默症。而小波变换分析则是用以设定可变脉冲间隔。

Description

可变间隔频率的磁刺激设备及方法
技术领域
本发明是有关于调整脑内活动的连续经颅磁刺激(repetitive transcranialmagnetic stimulation,rTMS)的方法，其中连续经颅磁刺激具有可调式脉冲，使用时间应足以调整患者脑内活动，使其生理状况或临床状况获得改善。分析患者的脑波图信号(Electroencephalography,EEG)进行小波转换后的结果作为可变脉冲间隔设定的依据。
背景技术
连续经颅磁刺激(rTMS)已被临床采用以治疗生理与内科不协调，例如:重度抑郁症、帕金森氏症、创伤后压力症候群PTSD、阿兹海默症、自闭症(ASD)、精神分裂症、疼痛管理以及其他。近期，Jin and Phillips于美国公开号第2009/0082690专利中公开一连续经颅磁刺激(rTMS)治疗的协议，其输出电场是依据患者的原有脑波图信号(EEG)做设定，企图调整患者的固有脑波信号。美国第9,308,385号专利则是用不同的方式，是根据生物学指针或贺尔蒙生物学指针调整连续经颅磁刺激仪(rTMS)。
连续经颅磁刺激(rTMS)是通过一种配备有脉冲电场的磁性线圈的仪器来操作，其频率与强度(intensity)可依据需求做设定。在本发明之前的的连续经颅磁刺激(rTMS)治疗只能在一设定好的强度上设定单一频率，而本发明所提供是一新奇的连续经颅磁刺激(rTMS)脉冲传递系统，具有可变脉冲间隔(variable pulse intervals)，涵盖多种频率与可变的输出强度。
发明内容
有鉴于此，本发明对哺乳类动物的脑内活动调整的方法是将哺乳类动物置于连续经颅磁刺激(rTMS)，依据个别的脑波图信号(EEG)特征调整可变脉冲间隔，持续治疗一段足够的时间以调整脑内活动，以达到生理状态或临床状态的改善。
在一实施例中，可变脉冲间隔的设定是依据哺乳类动物的脑波图信号(EEG)所产生的脑波信号图数据，经小波变换算法分析后而来。小波变换算法可辨识特殊的哺乳类/患者脑波信号图，然后该脑波信号图被用来产生连续的晶体管逻辑(TTL)或者其他触发脉冲，用以设定连续经颅磁刺激(rTMS)仪，用以提供多种脉冲间隔以及多种密度。待调整的脑内活动可以是一个或一个以上的频率，包含脑波频率带宽3-7Hz、脑波频率带宽8-13Hz、脑波频率带宽15-20Hz、脑波频率带宽35-45Hz，以及介于上述带宽内的次带宽族群。如果用以治疗患者的带宽介于8-13Hz，实际用以治疗患者的带宽则窄于前述，须依患者脑波图信号(EEG)的波动间隔的状况而定，例如105ms至110ms就是9.1至9.5Hz的带宽。当目标带宽的振幅增强、或者相关功率(Power)的强度增强、而且与临床及生理状况治疗有关的症状改善，就是调整成功。
任何生理状况及内科状况特殊状况所导致的不正常脑内活动均可藉本发明调整脑内活动以获得改善，亦即当目标脑波频率达到所需震幅或强度增强，就可看见成效。治疗状况包含但不受限于自闭症谱系障碍(ASD)、阿尔茨海默氏病(AD)、创伤后压力症候群(PTSD)、记忆障碍、忧郁、疼痛、上瘾、强迫症(OCD)、焦虑、帕金森氏症、高血压、性欲功能障碍、运动功能异常、幼儿身高小、压力、肥胖、睡眠障碍、饮食失调、注意力集中异常、言语异常、智力缺陷、认知异常、注意力缺陷多动障碍(ADHD)、精神分裂症、昏迷、双相情感障碍、耳鸣、纤维肌痛、慢性莱姆病，类风湿性关节炎和其他自身免疫疾病、痛风、糖尿病，关节炎、创伤康复、运动表现、认知改善和中风。
本发明经实际操作后，患者经过重复的连续经颅磁刺激(rTMS)仪的可变脉冲间隔治疗一段足够的时间后，患者的脑内活动经调整，达成生理或临床状况的改善。脑波图信号(EEG)仪从患者获取脑波图信号(EEG)数据，脑波图信号(EEG)数据经小波转换分析、撷取后，用以设定连续经颅磁刺激(rTMS)的可变脉冲间隔的频率与强度。小波变换算法从生理或内科状况达到理想改善的数据中，撷取出的特殊脑波图信号(EEG)及可变脉冲间隔档案。
有关本发明的其它功效及实施例的详细内容，配合附图说明如下。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请中记载的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图。
图1显示脑波信号(EEG)原始数据以及经小波分析所得的信号；
图2显示患者治疗前后的脑波信号(EEG)的能量谱。
符号说明
101脑波图原始信号数据
102脑波图信号模式 A0～An脉冲
C0～Cn高点 D0～Dn低点
T0～Tn时间 201强度
202频率 303治疗后表现
304治疗前表现
具体实施方式
术语“哺乳类”在此包含任何哺乳类，尤其是指人类。非人类的哺乳类包含非人类的灵长类、动物园动物、伴侣动物(狗，猫)、表演类动物(例如:赛马)、以及繁殖类动物。在此任何提及“人类”的叙述亦可适用于其他具有相同生理或内科状况特征的哺乳类。任何提及“患者”的叙述亦可适用于其他经历上述特殊情况的哺乳类动物(特别是人类)。
实施本发明时，脑波图信号(EEG)适用在生理状况或内科状况需要治疗的患者上。脑波图信号(EEG)模式是从特殊患者的脑波图信号(EEG)原始数据经过小波信号(wavelettransform)演算而来。脑波图信号(EEG)模式是用来对由连续经颅磁刺激(rTMS)仪产生的TTL脉冲、或其他触发器做可变脉冲间隔(variable pulse intervals)的设定。连续经颅磁刺激(rTMS)仪具有可变脉冲间隔，经过足够时间的治疗，就足以调整在生理状况或内科状况需要治疗的患者的脑内活动。在较佳实施例上，连续经颅磁刺激(rTMS)可变脉冲间隔被用于一段适当时间内调整患者脑内活动，令其生理状况或临床状况下获得改善。较佳的情况是，患者于状况评估后，一个月内每天治疗，或一个月内治疗五天/每周。连续经颅磁刺激(rTMS)仪通过撷取患者的脑波图信号(EEG)信号进行小波分析，来设定电磁刺激的可变脉冲间隔时间(variable pulse intervals)。特定的脑内活动或脑波频率是依据患者脑波图信号(EEG)来调整的。较佳脑内频率带宽是8-13Hz。电磁脉冲的最大密度设定一般受限于(或者低于)患者运动阀值(Motor threshold)。较佳的连续经颅磁刺激(rTMS)的最大脉冲能量/密度设定约为患者运动阀值的80％。
本发明的连续经颅磁刺激(rTMS)是利用受到认可的协议中关于磁性线圈的规定所规范。实际电磁刺激的设定时间根据每个临床反应而不同。较佳操作电磁刺激的方式是疗程中每分钟持续6秒，疗程可持续15-60分钟，但以30分钟为宜。磁性线圈置于靠近或抵靠患者头部，最好邻近最能操控脑波频率的地方。例如，如果治疗患者脑波频率带宽是8-13Hz区间，该连续经颅磁刺激(rTMS)的磁性线圈一般被放在患者额头(额叶区)处操作多种脉冲间隔。治疗患者的脉冲间隔频率不只一种，磁性线圈被放在靠近患者脑袋的脑波图信号(EEG)反应最慢的地方，亦即能量弱或没反应的地方。
可被治疗的患者包含人类/哺乳类动物或具有如下所述的脑波频率者。连续经颅磁刺激(rTMS)可变脉冲间隔可同时调整一个以上的脑波频率，或进行接续疗程。当治疗多个脑波频率时，连续经颅磁刺激(rTMS)可在患者头部多处传递不同脉冲间隔频率。或者使用多部连续经颅磁刺激(rTMS)仪于头部特定区域施做多重脉冲间隔。
需要治疗的患者的脑波图信号(EEG)被脑波图信号(EEG)仪搜集成数据，通过小波变换算法(wavelet transform algorithm)进行分析，并撷取出患者的脑波图信号模式(EEG signal pattern)102，如图1所示，用以设定连续经颅磁刺激(rTMS)的可变脉冲间隔来治疗患者。
如图1所示，患者个别的脑波图信号模式102是通过对脑波图原始信号(EEG)数据101进行小波变换算法而得出，脑波图信号(EEG)模式具有一连串具周期变化的时间序列A0,A1,A2…An以及具有强度变化的震幅设定C1-D1,C2–D2,C3-D3…Cn-Dn，功率强度的设定取自于每个脑波图信号(EEG)的高点(C)与低点(D)。连续经颅磁刺激(rTMS)所启动的脉冲来自于每个经小波分析的高峰值，如图1所示，有n个脉冲-A1,A2,…An，其中n>1且可能每列脉冲多于或少于3个脉冲，视脑波图信号(EEG)及小波数据而定。脉冲的时间”T”，如图中T1,T2,…Tn，均是来自小波分析脑波图信号(EEG)后所得的值。针对脑波频率8-13Hz所设定脉冲时间都会不同，但均介于75-125毫秒(ms)。
图2是患者脑波图信号(EEG)能量的图谱，其强度(Power)201相对频率202的配置以显示治疗前304及治疗后303的表现(Profile)。
一旦患者的脑波图信号(EEG)经小波变换算法分析完成，将用于设定连续经颅磁刺激(rTMS)的可变脉冲间隔以治疗患者。
此外，本发明是与一改良的连续经颅磁刺激(rTMS)仪有关，其包含一个用以传递连续经颅磁刺激(rTMS)具有可变脉冲间隔(variable pulse intervals)的改良方法有关。在此实施例中，连续经颅磁刺激(rTMS)仪用以设定的可变脉冲间隔，其中用以治疗患者的较佳的尖峰或密度值应低于患者的运动阀值40-90％为宜，其余的脉冲密度会与相应的脑波图信号(EEG)波振幅成正比。
以上所述的实施例及/或实施方式，仅是用以说明实现本发明技术的较佳实施例及/或实施方式，并非对本发明技术的实施方式作任何形式上的限制，任何本领域技术人员，在不脱离本发明内容所公开的技术手段的范围，当可作些许的更动或修改为其它等效的实施例，但仍应视为与本发明实质相同的技术或实施例。

Claims (9)

1.一种连续经颅磁刺激仪的操作方法，适用调整一哺乳类动物脑内活动，其特征在于，其方法包含:
a.从该哺乳类动物收集一脑波图原始信号数据，对该脑波图原始信号数据进行小波变换以产生一脑波图信号模式；以及
b.运用该脑波图信号模式来控制连续经颅磁刺激仪，藉以产生具有可变脉冲间隔的连续经颅磁刺激脉冲。
2.如权利要求1所述的操作方法，其特征在于，该哺乳类动物脑内活动包含至少一个或多个脑波带宽介于3和7Hz、8和13Hz、15和20Hz，以及35和45Hz。
3.如权利要求2所述的操作方法，其特征在于，该哺乳类动物脑内活动包含至少一个脑内频率介于8和13Hz。
4.如权利要求1所述的操作方法，其特征在于，该可变脉冲间隔是对该哺乳类动物的脑波图信号进行小波变换演算而撷取得到。
5.如权利要求4所述的操作方法，其特征在于，被调整的脑内活动包含至少一个脑波频率介于3和7Hz、8和13Hz、15和20Hz或35和45 Hz。
6.如权利要求1所述的操作方法，其特征在于，该些连续经颅磁刺激脉冲的最大强度低于该哺乳类动物的一运动阀值。
7.如权利要求6所述的操作方法，其特征在于，该些连续经颅磁刺激脉冲的强度介于该运动阀值的40-90％。
8.一种可程序连续经颅磁刺激设备，其特征在于，包含有一电磁线圈已发送具有可变脉冲间隔的连续经颅磁刺激脉冲。
9.如权利要求9所述的可程序连续经颅磁刺激设备，其特征在于，该可变脉冲间隔是由小波变换演算而得到。
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