Status:
RECRUITING
German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Storz Medical AG
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-85 years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- i. 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
- i. 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
Key Trial Info
Start Date :
August 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06313944
Start Date
August 6 2025
End Date
October 1 2026
Last Update
November 26 2025
Active Locations (4)
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1
Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie
Potsdam, Brandenburg, Germany, 14467
2
Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen
Bonn, North Rhine-Westphalia, Germany, 53127
3
Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
Kempen, Germany, 47906
4
Praxis Dr. Schwarz
Ulm, Germany, 89073