German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
Recruiting · NCT06313944 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heinrich-Heine University, Duesseldorf
View the official record on ClinicalTrials.gov →Interventions studied
Registry
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
6 locations listed.
- Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation - Kempen, Germany
- Praxis Dr. Schwarz - Ulm, Germany
- Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie - Potsdam, Brandenburg, Germany
- Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie - Oldenburg, Lower Saxony, Germany
- Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen - Bonn, North Rhine-Westphalia, Germany
- Neurologische Praxis Prof. Wojtecki - Neuss, North Rhine-Westphalia, Germany