NCT06313944 · RECRUITING
German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
This German registry is tracking real-world use of Transcranial Pulse Stimulation (TPS), a non-invasive brain stimulation device already approved in Europe, in people diagnosed with Alzheimer's disease. Researchers are collecting safety data, side effects, and cognitive scores across multiple clinics. This is a post-market registry, not a randomized trial, so it is documenting how the device performs in routine care rather than testing it in a controlled experiment for the first time.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-10