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NCT Number: NCT06313944

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie, Potsdam, Brandenburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registry

Diagnostic Test

Clinical data collection of patients scheduled for on-label treatment

Primary outcomes

  1. Number of (Serious) Adverse Events

    Time frame: through study completion, an average of 1 year

    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)

  2. Number of adverse device effects

    Time frame: through study completion, an average of 1 year

    Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)

Secondary outcomes

  1. ADAS

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

    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)

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

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

    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)

  3. BDI-II

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

    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)

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

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

    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)

  5. Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL)

    Time frame: 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) 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)

Other outcomes

  1. Numeric Rating Scale (NRS) for the main symptom

    Time frame: 12 months

    Numeric Rating Scale (NRS) for the main symptom

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Wojtecki, Prof. Dr.

CONTACT

[email protected]

+492118106756

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • Storz Medical AG

Registry information

Official study title

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

Acronym: GE-R-A-TPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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