Alzheimer’s successful treatment technology
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Transcranial Pulse Stimulation (TPS) is an efficacy proven new technique that delivers short acoustic pulses with an ultrasound frequency range. The technique allows unprecedented focal brain stimulation reaching depths of as much as 8 cm in the brain. Developed by Storz Medical, the system (NEUROLITH ®) reflects an unparalleled advancement in the field of transcranial stimulation. After seven years of research and development the Neurolith was introduced just over two years ago and has been rapidly embraced with now 60 clinics treating patients around the globe.
Doctors, including Geriatricians, Geriatric Psychologists, Neurologists, Psychiatrists, and other trained clinicians to summarize Neurolith patient treatment results “promotes/prevents decline of cognitive capabilities with an 85-90% success rate. “
Unprecedented Spatial and Depth Focality
The Neurolith is the only complete acoustic transcranial stimulation system that has been rigorously clinically validated. In addition to the transducer probe, the integrated system comprises of a real-time stimulation visualization software based on individualized MRI (BodyTrack ®), neuronavigation for precise probe placement, stimulation documentation, and access to subject database. Over 1500 stimulation sessions as of February 2019 have been conducted validating the application of this new innovative technology.
Neurolith pressure distribution shows that penetration depths of as much as 8 cm are obtained. The stimulation profile is also spatially restricted as expected with acoustic wave stimulation.
Transcranial Pulse Stimulation focal energy transmission has been vigorously tested via both simulations and in-vitro experiments. The numerical models were derived from CT scans of donors. The position of the TPS source in relation to the skull was recreated exactly based on experimental measurements. The simulations were performed in Matlab (Mathworks, USA) and k-wave toolbox. For invitro measurements, human skull and brain samples were used. The pressure pulses were measured using a needle hydrophone fixed on a stage. All pressure waves were released at a drive level of 0.25 mJ/mm 2, and at a pulse repetition frequency of 2 Hz. First, a reference acoustic field measurement was performed in free water. Then, a section of human skull was placed in front of the handpiece. The relative position of the handpiece to the skull was determined from photographic acquisitions during the measurements. See full details in Beisteiner 2019.
Mechanism of Action
The key mechanism induced by TPS® is mechanotransduction. Specifically, this stimulation modality has been shown to promote growth factor expression, primarily VEGF 1, 2, improve cerebral blood flow, promote formation of new blood vessels (angiogenesis), and nerve regeneration. An additional effect is the release of nitric oxide (NO) 3, which leads to direct vasodilation and improved blood circulation.
The following biological effects of TPS® have been reported thus far:
- Stimulation of vascular growth factors (VEGF) 1, 2
- Release of nitric oxide (NO) 3, which leads to vasodilation, increased metabolic activity and angiogenesis and has an anti-inflammatory effect
- Migration and differentiation of stem cells 2, 4
- Mechanotransduction 4
- Stimulation of mechanosensitive ion channels 4
- Increase in cell permeability 5
- Stimulation of BDNF 6
Validated research- and clinical- grade technology
The Neurolith device has been rigorously validated in clinical trials. The system received European Union (CE) approval for the treatment of a neurological disorder in 2018. Several other international regulatory approvals are underway. The system is currently investigational (research use) in US and Canada. The indications for which Neurolith is currently being tested for include Spinal Cord Injury, Stroke, Parkinson’s, Alzheimer’s Disease, Unresponsive Wakefulness, and many more.
The first complete system for Transcranial Acoustic Stimulation
The Neurolith system comprises of hand-held probe (left), placement of which is precisely guided by the neuronavigation system(middle), and the real-time stimulation activation software (right).
The Neurolith system has been designed and developed as a complete system from the ground up. It starts with the special ergonomic shape of the TPS handpiece that minimizes hand fatigue to facilitate easy stimulation administration on the subject. The coupling surface adapts easily to any shape of the head, making stimulation with focused pulses simple and efficient. The 3D infrared camera technology ensures high-precision tracking between the handpiece and the tracking glasses. The software provides real-time visualization and stimulation documentation of TPS administration. The synergy between the state-of-art navigation technology and software enables seamless and efficient interaction between the operator and the subject.
Quality and Reliability
The Neurolith device is backed by over 30 years of experience in acoustic wave stimulation technology by Storz Medical. The system is a clinic-ready medical device with all relevant IEC certifications complete and manufactured from medical device quality system certified facility.
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References
1. Low-energy extracorporeal shock wave therapy for promotion of vascular endothelial growth factor expression and angiogenesis and improvement of locomotor and sensory functions after spinal cord injury, J Neurosurg Spine, Vol. 25(6), Pages 745–755, 2016 Yahata, K. et al.
2. Molecular mechanisms of the angiogenic effects of low-energy shock wave therapy: roles of mechanotransduction, Am J Physiol Cell Physiol, Vol. 311(3), C378–C385, 2016 Hatanaka, K. et al.
3. Extracorporeal shock waves: From lithotripsy to anti-inflammatory action by NO production, Nitric Oxide, Vol. 12(2), 89–96, 2005 Mariotto, S. et al.
4. Shock wave as biological therapeutic tool: From mechanical stimulation to recovery and healing, through mechanotransduction, Int J Surg., Dec. 24(Pt B), 147-153, 2015 d´Agostino, M. C. et al.
5. Shock wave–induced permeabilization of mammalian cells, Phys Life Rev., 26-27:1-38, 2018 López-Marín, L. M. et al.
6. Low-Intensity Extracorporeal Shock Wave Therapy Enhances Brain-Derived Neurotrophic Factor Expression through PERK/ATF4 Signaling Pathway, Int J Mol Sci., Feb 16;18(2). pii: E433, 2017 Wang, B. et al.
7. Transcranial Pulse Stimulation with Ultrasound in Alzheimer’s disease- A new navigated focal brain therapy. bioRxiv preprint posted online Jun 2019. Beistener et al
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