Abstract
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.
Highlights
Several publications have reported the potential of ultrasound to stimulate the human brain in a highly focal and precisely targeted manner
We introduce a new ultrasound stimulation technique, which was developed for clinical applications by an interdisciplinary consortium for brain stimulation (MH), clinical neuroscience (RB), clinical ultrasound (HLB) and ultrasound technology (EMar)
Transcranial Pulse Stimulation (TPS) data simulations 3D simulation of temporal peak intensities showed that a highly focal energy pulse can be generated through the skull
Summary
Several publications have reported the potential of ultrasound to stimulate the human brain in a highly focal and precisely targeted manner. In contrast to electrophysiological brain stimulation techniques that often suffer from conductivity effects (Minjoli et al 2017) and lack of deep stimulation capabilities (Spagnolo 2018), the target for ultrasound-based neuromodulation can be spatially distinct, highly focal, and is not restricted to superficial layers of the brain. For brain therapy, this enables a controlled modulation of a specific brain region with reduced probability of producing unwanted co-stimulations of other brain areas. Initial clinical data concerning non-navigated stimulation (Lohse-Busch et al 2014) and a case report (Monti et al 2016) are available
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