German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation (GE-R-A-TPS)

German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Diagnostic test: Registry

Detailed Description

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. Adverse effects and adverse events without a clear causal relationship will be documented in terms of frequency and severity. Furthermore, the progression of improvement in Alzheimer's symptoms as a result of TPS treatment is summarized in various neuropsychological scales.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lars Wojtecki, Prof. Dr.; Phone Number: +492118106756; Email: wojtecki@uni-duesseldorf.de

Study Locations

• Germany
  • Kempen, Germany, 47906
    • Withdrawn
    • Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
  • Ulm, Germany, 89073
    • Recruiting
    • Praxis Dr. Schwarz
    • Contact: Alexander Schwarz, Dr. med.; Phone Number: 6620 +49731922; Email: kontakt@tps-zentrum.de
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • Recruiting
      • Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie
      • Contact: Martin Südmeyer, Prof. Dr. med.; Phone Number: +4933124137102; Email: martin.suedmeyer@klinikumevb.de
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26122
      • Not yet recruiting
      • Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie
      • Contact: Karsten Witt, Prof. Dr. med.; Phone Number: +49 441 236 649; Email: karsten.witt@evangelischeskrankenhaus.de
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Not yet recruiting
      • Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen
      • Contact: Ullrich Wüllner, Prof. Dr. med.; Phone Number: +49 22828713166; Email: Ullrich.Wuellner@ukbonn.de
    • Neuss, North Rhine-Westphalia, Germany, 41460
      • Not yet recruiting
      • Neurologische Praxis Prof. Wojtecki
      • Contact: Lars Wojtecki, Prof. Dr. med.; Phone Number: +49 1520 54 53 361; Email: info@brain-clinic.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

AD Patients undergoing TPS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Clinical Alzheimer's syndrome treated with TPS; Patients with 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 that have planned treatment with TPS	Diagnostic test: Registry; Clinical data collection of patients scheduled for on-label treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of (Serious) Adverse Events	Number of adverse events (without causal relationship to therapy) AE, SAE (query after the first 6-cycle block and before each booster) scaling according to NRS (1-10) for each ADE (query before each stimulation)	through study completion, an average of 1 year
Number of adverse device effects	Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADAS	Alzheimer's Disease Asessment Scale (ADAS) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Mini Mental State Examination (MMSE) baseline and follow- up	Mini Mental State Examination (MMSE) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
BDI-II	BDI-II baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Clinical Dementia Rating Sum of Boxes Score (CDR-SB)	Clinical Dementia Rating Sum of Boxes Score (CDR-SB) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL)	Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL) at baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) for the main symptom	Numeric Rating Scale (NRS) for the main symptom	12 months

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Storz Medical AG
• Investigators: Principal Investigator: Lars Wojtecki, Prof. Dr., Heinrich-Heine-Universität

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Alzheimer Disease; Transcranial Pulse Wave Stimulation (TPS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: GE-R-A-TPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No