German registry collecting results of transcranial pulse stimulation for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective registry will collect real-world data on transcranial pulse stimulation (TPS) delivered to patients with Alzheimer's disease as part of post-market clinical follow-up. Participating centers will document stimulation parameters, adverse events, and cognitive, affective, and patient-reported outcome measures across visits to help optimize the stimulation protocol. Enrollment aims for at least 100 adults (ages 18–85) with clinical Alzheimer's syndrome, with MRI, CSF, or PET biomarkers included when available. TPS treatments are performed under specialist supervision at participating neurology or psychiatry centers and outcomes are tracked longitudinally.

Why it matters

Who can join: the full rules

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's running

• Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie
  Potsdam, Brandenburg, Germany Recruiting
• Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie
  Oldenburg, Lower Saxony, Germany Recruiting
• Neurologische Praxis Prof. Wojtecki
  Neuss, North Rhine-Westphalia, Germany Recruiting
• Praxis Dr. Schwarz
  Ulm, Germany Recruiting
• Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen
  Bonn, North Rhine-Westphalia, Germany Not yet recruiting
• Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
  Kempen, Germany Withdrawn

Study contacts

• Principal investigator: Lars Wojtecki, Prof. Dr. — Heinrich-Heine-Universität
• Study coordinator: Lars Wojtecki, Prof. Dr.
• Email: wojtecki@uni-duesseldorf.de
• Phone: +492118106756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.