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Drug-free, Minimally Invasive Transcranial Pulse Stimulation Alzheimer treatment trial in Austria, Recruiting since 2017
HowDoYouDeal
Posted: Tuesday, November 26, 2019 9:10 PM
Joined: 2/17/2019
Posts: 302


 
  Scheduled to end January of 2020
Contact: Roland Beisteiner, Prof. +43 1 401600 roland.beisteiner@meduniwien.ac.at  
 
 
 Trial record 1 of 1 for:    storz | Alzheimer Disease
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Brain Stimulation for Neurological Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770182
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 13, 2018
 
Contacts
Contact: Roland Beisteiner, Prof. +43 1 401600 roland.beisteiner@meduniwien.ac.at  
 
Sponsor:
Collaborator:
  
 
 Medical University of Vienna
Information provided by (Responsible Party):
Storz Medical AG
 
Study Details
Study Description
Go to 
 
Brief Summary:
This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Condition or disease Intervention/treatment Phase Alzheimer DiseaseDevice: NEUROLITHNot Applicable
Study Design
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  Study Type : Interventional  (Clinical Trial)

 

Estimated

Enrollment : 60 participants Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment

 

Official Title:

Brain Stimulation for Neurological Patients

Study Start Date : January 24, 2017

 

Actual

 

Estimated

Primary Completion Date : January 1, 2020 Estimated Study Completion Date : January 1, 2020

STORZ MEDICAL’s NEUROLITH® receives CE approval – Transcranial Pulse Stimulation (TPS) on the central nervous system of patients with Alzheimer’s disease

Neurolith_CE_Approval

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 them significantly.

 The data also showed that the improvements last for at least 3 months after the completion of the TPS treatment series.

  On 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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Medical University of Vienna (School and university)

If you can't wait for the new school year to begin, then take time to visit Medical University of Vienna. Read the practical information to make your visit to this university even more enjoyable. Take time to discover the wide range of activities you can choose from near Medical University of Vienna as well as our selection of local hotels. Watch the video of your hotel and read the reviews before booking the ideal room with one of our partners!


 
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Practical Information

Address: Spitalgasse 23

Zip code: 1090

City: Vienna

Region: Wien

Country: Austria

Phone 1: +43 (1) 40160 10000

Fax: +43 (1) 40160 910000

Customer reviews

 

Activities nearby

Spa and swimming pools
  • 1,457 ydHolmes Place Health Club Wien - Boerseplatz:
Monument
  • 1.1 miImperial Apartments:
Theatre and opera
  • 1 miNeue Oper Wien:
  • 539 ydVolksoper Wien:
  • 558 ydsireneOperntheater:
Museum
  • 676 ydLiechtenstein Museum:
School and university
  • 1,475 ydVienna University of Economics and Business:
  • 803 ydFHWien University of Applied Sciences of WKW:
 
 
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HowDoYouDeal
Posted: Tuesday, November 26, 2019 9:14 PM
Joined: 2/17/2019
Posts: 302


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 the device.

 Only in the UK

 
 

Transcranial Pulse Stimulation (TPS®) in Alzheimer’s Disease

Product video MASTERPUL ONE


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.

TPS® enables targeted stimulation of cerebral regions.

Biological effects of TPS®

  • Mechanotransduction6
  • Increase in cell permeability7
  • Stimulation of mechanosensitive ion channels6
  • Release of nitric oxide (NO)5, which leads to vasodilation, increased metabolic activity and angiogenesis and has an anti-inflammatory effect
  • Stimulation of vascular growth factors (VEGF)3,4
  • Stimulation of BDNF8
  • Migration and differentiation of stem cells4,6

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®

  • 6 treatment sessions in 2 weeks
  • Outpatient treatment (30 minutes/session)
  • Painless and without side effects
  • Personalized treatment based on MRI data
  • Adjuvant cognitive training not required
  • Shaving of the scalp not required
  • No immobilization of the patient during treatment

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® treatmentReal-time visualization of TPS® treatment

Advantages of the BodyTrack® software

  • Use of personalized MRI data
  • Visualization of MRI data in 3 planes (axial, coronal, sagittal)
  • Coloured visualization of the treatment region
  • Real-time visualization of TPS® pulse distribution
  • Continuous visualization and documentation of the energy applied and of treatment progress

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.

Transcranial Pulse Stimulation (TPS®) in Alzheimer’s Disease3D camera with patient and handpiece position detection / Calibration probe and tracking glasses with markers / TPS® handpiece with markers

Advantages of the NEUROLITH®

  • Focused stimulation of deep cerebral regions
  • Personalized 3D visualization of patient’s head
  • 3D infrared camera system for precise cerebral tracking
  • USB interface for MRI data import
  • Patient database

Publications:
3Yahata, 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, 2016
4Hatanaka, 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, 2016
5Mariotto, S. et al.: Extracorporeal shock waves: From lithotripsy to anti-inflammatory
action by NO production, Nitric Oxide, Vol. 12(2), 89–96, 2005
6d´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

 
 
 
 
STORZ MEDICAL AG
Lohstampfestrasse 8 8274 Tägerwilen
Switzerland Tel.: +41 (0)71 677 45 45
Fax: +41 (0)71 677 45 05
www.storzmedical.com  

HowDoYouDeal
Posted: Tuesday, November 26, 2019 9:50 PM
Joined: 2/17/2019
Posts: 302


2 weeks in Vienna, in January

 

Vienna: 540 properties found



Lane Simonian
Posted: Tuesday, November 26, 2019 11:12 PM
Joined: 12/12/2011
Posts: 4656


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.

The long-term high-frequency repetitive transcranial magnetic stimulation does not induce mRNA expression of inflammatory mediators in the rat central nervous system.