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Drug-free, Minimally Invasive Transcranial Pulse Stimulation Alzheimer treatment trial in Austria, Recruiting since 2017
Double (Participant, Outcomes Assessor)
Study Start Date :
January 24, 2017
Primary Completion Date :
January 1, 2020
Estimated Study Completion Date :
January 1, 2020
In December 2018, STORZ MEDICAL has received the CE approval for the NEUROLITH®, a new therapy system for the treatment of neurological diseases.
The technology behind the NEUROLITH® is called
Transcranial Pulse Stimulation (TPS). TPS consists of short acoustic
pulses with an ultrasound frequency range that permits a well-focused
stimulation of the brain at a depth of up to 5 cm.
The pivotal study for the NEUROLITH®
showed that TPS can not only maintain the cognitive abilities of
patients with mild to moderate Alzheimer’s disease, but even improve
The data also showed that the improvements last for
at least 3 months after the completion of the TPS treatment series.
average, cognition was improved by 10 points on the CERAD scale. This
was also confirmed by patients and their relatives: in everyday life,
they noticed improved verbal abilities and an improved memory, which
indirectly led to an increase in social interaction.
Some patients had
an improved sense of direction that enabled them to do their shopping
independently again and to go home afterwards.
Further information on the new NEUROLITH® will soon be available on the STORZ MEDICAL website.
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Note: Certain devices and references made herein to specific
indications of use may have not received clearance or approval by the
United States Food and Drug Administration. Practitioners in the United
States should first consult with their local STORZ MEDICAL
representative in order to ascertain product availability and specific
labeling claims. Federal (USA) law restricts certain devices referenced
herein to sale, distribution, and use by, or on the order of a
physician, dentist, veterinarian, or other practitioner licensed by the
law of the State in which she/he practices to use or order the use of
Only in the UK
Transcranial Pulse Stimulation (TPS®) in Alzheimer’s Disease
Applied knowledge in neurology – The TPS® method of action
The key mechanism induced by TPS® is mechanotransduction. The stimulation of growth factors, primarily VEGF3,4,
not only improves cerebral blood flow, but also promotes the formation
of new blood vessels (angiogenesis) and nerve regeneration. An
additional effect is the release of nitric oxide (NO)5, which leads to direct vasodilation and improved blood circulation.
TPS® enables targeted stimulation of cerebral regions.
Biological effects of TPS®
TPS® can stimulate deep cerebral regions, reaching as much as 8 cm into the brain. Owing to the short duration of the TPS®
stimulation, tissue heating is avoided. The pulses applied to the
treatment area thus develop their maximum clinical effectiveness. TPS®
treatment is performed through the closed skull. The patient is not
immobilized during the treatment and able to move freely. TPS®
treatment has been shown to significantly improve CERAD test
performance and to reduce Beck’s depression index in patients with mild
to moderate dementia. Over 1500 treatments have already been performed
using the NEUROLITH® system.
Advantages of TPS®
BodyTrack® – Treatment documentation in real time
Real-time tracking of the handpiece position enables automatic
visualization of the treated regions. The use of personalized MRI data
allows specific characteristics of the patient’s brain to be taken into
account. Every time the handpiece position changes, the visualization of
the target regions in the loaded MRI scans is automatically updated.
The energy applied is highlighted in colour. The BodyTrack® software is a
unique tool for the visualization and control of the TPS® pulses
applied and of treatment progress.
Real-time visualization of TPS® treatment
Advantages of the BodyTrack® software
NEUROLITH® – The perfect solution to facilitate Alzheimer’s treatment
NEUROLITH® – an innovative system with convincing design features! The special ergonomic shape of the TPS®
handpiece minimizes hand fatigue to facilitate treatment working
directly on the patient. The coupling surface adapts easily to any shape
of head, making the treatment with focused pulses simple and efficient.
The NEUROLITH® software includes patient management functionalities with retrievable data and recommended treatment parameters.
camera with patient and handpiece position detection / Calibration
probe and tracking glasses with markers / TPS® handpiece with markers
Advantages of the NEUROLITH®
K. et al.: 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, 20164Hatanaka,
K. et al.: 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, 20165Mariotto, S. et al.: Extracorporeal shock waves: From lithotripsy to anti-inflammatory action by NO production, Nitric Oxide, Vol. 12(2), 89–96, 20056d´Agostino,
M. C. et al.: 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 7López-Marín, L. M. et al.: Shock wave–induced permeabilization of mammalian cells, Phys Life Rev., 26-27:1-38, 2018 8Wang,
B. et al.: 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
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2 weeks in Vienna, in January
These don't quite fit here, but they partially help satisfy my desire to find a mechanism.
Transcranial magnetic stimulation as an antioxidant
In the last decades, different transcranial magnetic stimulation protocols have been developed as a therapeutic tool against neurodegenerative and psychiatric diseases, although the biochemical, molecular and cellular mechanisms underlying these effects are not well known. Recent data show that those magnetic stimulation protocols showing beneficial effects could trigger an anti-oxidant action that would favour, at least partially, their therapeutic effect. We have aimed to review the molecular effects related to oxidative damage induced by this therapeutic strategy, as well as from them addressing a broader definition of the anti-oxidant concept.