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

NCT06313944 | Recruiting

• 1 other identifier: GE-R-A-TPS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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

Alzheimer Disease

Keywords

Alzheimer Disease; Transcranial Pulse Wave Stimulation (TPS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• ADAS

  Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

• Mini Mental State Examination (MMSE) baseline and follow- up

  Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

• BDI-II

  Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

• Clinical Dementia Rating Sum of Boxes Score (CDR-SB)

  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)

  Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

Other Outcomes (1)

• Numeric Rating Scale (NRS) for the main symptom

  12 months

Study Arms (1)

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

Interventions

Registry DIAGNOSTIC_TEST

Clinical data collection of patients scheduled for on-label treatment

Patients with Clinical Alzheimer's syndrome treated with TPS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AD Patients undergoing TPS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Storz Medical AG: collaborator

Study Sites (4)

Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie

Potsdam, Brandenburg, 14467, Germany

RECRUITING

Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen

Bonn, North Rhine-Westphalia, 53127, Germany

NOT YET RECRUITING

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

Kempen, 47906, Germany

RECRUITING

Praxis Dr. Schwarz

Ulm, 89073, Germany

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lars Wojtecki, Prof. Dr.

  Heinrich-Heine-Universität

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Wojtecki, Prof. Dr.

CONTACT

+492118106756; wojtecki@uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

DE (4)