Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06313944

German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-11-26

100

Participants Needed

4

Research Sites

60 weeks

Total Duration

On this page

Sponsors

H

Heinrich-Heine University, Duesseldorf

Lead Sponsor

S

Storz Medical AG

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Clinical Alzheimer's syndrome with gradually progressive memory decline and impaired daily activities for more than six months
  • MRI scan, cerebrospinal fluid, or PET biomarker evidence (optional) following NIA-AA criteria for Alzheimer's disease or continuum
  • TPS treatment performed under supervision of a neurological or psychiatric specialist at a specialized center
Not Eligible

You will not qualify if you...

  • Intracerebral pathologies unrelated to Alzheimer's disease such as Fazekas grade 3 vascular encephalopathy, tumors, vascular malformations, pregnancy, metal implants, cerebral amyloid angiopathy according to Boston criteria, or antibody therapy
  • Blood coagulation disorders or use of oral anticoagulants
  • Epilepsy
  • Medical conditions that prevent compliance with the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie

Potsdam, Brandenburg, Germany, 14467

Actively Recruiting

2

Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen

Bonn, North Rhine-Westphalia, Germany, 53127

Not Yet Recruiting

3

Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation

Kempen, Germany, 47906

Actively Recruiting

4

Praxis Dr. Schwarz

Ulm, Germany, 89073

Actively Recruiting

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Research Team

L

Lars Wojtecki, Prof. Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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