German registry collecting results of transcranial pulse stimulation for Alzheimer's disease
German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)
This registry will collect safety and outcome data to see if transcranial pulse stimulation helps adults with Alzheimer's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 4 sites (Potsdam, Brandenburg and 3 other locations) |
| Trial ID | NCT06313944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–85 with a clinically diagnosed progressive Alzheimer's syndrome (memory decline for more than six months) who receive TPS at a participating neurology or psychiatry center.
Not a fit: Patients with major unrelated intracerebral pathology (for example severe vascular encephalopathy Fazekas grade 3, tumors) or other contraindications to TPS may not receive benefit from this treatment.
Why it matters
Potential benefit: If successful, TPS could offer a safe, noninvasive option that improves cognitive symptoms or slows decline for some people with Alzheimer's disease.
How similar studies have performed: Early small-scale studies and case series of TPS have reported acceptable safety and preliminary cognitive improvements, but larger real-world data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Potsdam, Brandenburg and 3 other locations
- Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie — Potsdam, Brandenburg, 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 (Recruiting)
- Praxis Dr. Schwarz — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Lars Wojtecki, Prof. Dr. — Heinrich-Heine-Universität
- Study coordinator: Lars Wojtecki, Prof. Dr.
- Email: wojtecki@uni-duesseldorf.de
- Phone: +492118106756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.