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German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

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About this study

This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.

Condition
Alzheimer Disease
Tested
Registry
Sponsor
Heinrich-Heine University, Duesseldorf

Who can join

Age
18 to 85 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Maximum age: 85 years
  • Study condition: Alzheimer Disease
  • Age = 18 to 85 ii.
  • N\>=100, clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months iii.
  • MRI scan, in vivo evidence from CSF and/or PET using the NIA-AA criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional.
  • These biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration \[AT(N)\], which can be detected on imaging and in biofluids.
  • If possible, patients with Alzheimer's disease (AD) or Alzheimer's continuum should be included.
  • iv. TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist

Exclusion 4

  • Relevant intracerebral pathologies not related to Alzheimer's disease, such as vascular encephalopathy Fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, CAA according to Boston criteria, Z.n. or during antibody therapy ii.
  • Blood coagulation disorders or oral anticoagulation iii.
  • Epilepsy iv.
  • Medical conditions leading to non-compliance with the protocol

Where

6 sites, 5 recruiting

Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie

Oldenburg, Lower Saxony, Germany

Recruiting

Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie

Potsdam, Brandenburg, Germany

Recruiting

Praxis Dr. Schwarz

Ulm, Germany

Recruiting

Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen

Bonn, North Rhine-Westphalia, Germany

Recruiting

Neurologische Praxis Prof. Wojtecki

Neuss, North Rhine-Westphalia, Germany

Recruiting

Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation

Kempen, Germany

Contact

Potential match only. Final eligibility is determined by the study team.