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Transcranial Pulse Stimulation with Ultrasound in Alzheimer's Disease-A New Navigated Focal Brain Therapy.
Advanced Science ( IF 14.3 ) Pub Date : 2019-12-23 , DOI: 10.1002/advs.201902583
Roland Beisteiner 1 , Eva Matt 1 , Christina Fan 2 , Heike Baldysiak 3 , Marleen Schönfeld 1 , Tabea Philippi Novak 1 , Ahmad Amini 1 , Tuna Aslan 1 , Raphael Reinecke 1 , Johann Lehrner 1 , Alexandra Weber 1 , Ulrike Reime 3 , Cédric Goldenstedt 2 , Ernst Marlinghaus 2 , Mark Hallett 4 , Henning Lohse-Busch 3
Affiliation  

Ultrasound-based brain stimulation techniques may become a powerful new technique to modulate the human brain in a focal and targeted manner. However, for clinical brain stimulation no certified systems exist and the current techniques have to be further developed. Here, a clinical sonication technique is introduced, based on single ultrashort ultrasound pulses (transcranial pulse stimulation, TPS) which markedly differs from existing focused ultrasound techniques. In addition, a first clinical study using ultrasound brain stimulation and first observations of long term effects are presented. Comprehensive feasibility, safety, and efficacy data are provided. They consist of simulation data, laboratory measurements with rat and human skulls and brains, in vivo modulations of somatosensory evoked potentials (SEP) in healthy subjects (sham controlled) and clinical pilot data in 35 patients with Alzheimer's disease acquired in a multicenter setting (including neuropsychological scores and functional magnetic resonance imaging (fMRI)). Preclinical results show large safety margins and dose dependent neuromodulation. Patient investigations reveal high treatment tolerability and no major side effects. Neuropsychological scores improve significantly after TPS treatment and improvement lasts up to three months and correlates with an upregulation of the memory network (fMRI data). The results encourage broad neuroscientific application and translation of the method to clinical therapy and randomized sham-controlled clinical studies.

中文翻译:

超声经颅脉冲刺激治疗阿尔茨海默病——一种新的导航局灶性脑疗法。

基于超声的脑刺激技术可能成为一种强大的新技术,以集中和有针对性的方式调节人脑。然而,对于临床脑刺激来说,不存在经过认证的系统,并且当前的技术必须进一步发展。这里介绍了一种基于单超短超声脉冲(经颅脉冲刺激,TPS)的临床超声技术,该技术与现有的聚焦超声技术明显不同。此外,还提出了第一项使用超声脑刺激的临床研究和对长期影响的首次观察。提供全面的可行性、安全性和有效性数据。它们包括模拟数据、大鼠和人类头骨和大脑的实验室测量、健康受试者体感诱发电位 (SEP) 的体内调节(假对照)以及在多中心环境中获得的 35 名阿尔茨海默病患者的临床试验数据(包括神经心理学评分和功能磁共振成像(fMRI))。临床前结果显示较大的安全裕度和剂量依赖性神经调节。患者调查显示治疗耐受性高且无重大副作用。TPS 治疗后神经心理学评分显着改善,改善可持续长达三个月,并且与记忆网络的上调相关(fMRI 数据)。结果鼓励广泛的神经科学应用并将该方法转化为临床治疗和随机假对照临床研究。
更新日期:2019-12-23
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