Registry: Clinical data collection of patients scheduled for on-label treatment
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
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 Criteria:
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
Primary outcome measure(s)
Number of (Serious) Adverse Events — through study completion, an average of 1 year Number of adverse events (without causal relationship to therapy) AE, SAE (query after the first 6-cycle block and before each booster) scaling according to NRS (1-10) for each ADE (query before each stimulation)
Number of adverse device effects — through study completion, an average of 1 year Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)
Trial sites (6)
Facility
City
Region
Status
Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie
Potsdam
Brandenburg
Recruiting
Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie
Oldenburg
Lower Saxony
Recruiting
Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen
Bonn
North Rhine-Westphalia
Not Yet Recruiting
Neurologische Praxis Prof. Wojtecki
Neuss
North Rhine-Westphalia
Not Yet Recruiting
Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
Kempen
Germany
Withdrawn
Praxis Dr. Schwarz
Ulm
Germany
Recruiting
More Heinrich-Heine University, Duesseldorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.