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

Heinrich-Heine University, Duesseldorf100 enrolled

Overview

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

100

Conditions

Alzheimer Disease

Interventions

RegistryDIAGNOSTIC_TEST

Clinical data collection of patients scheduled for on-label treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (6)

Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie

Potsdam, Brandenburg, Germany

RECRUITING

Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie

Oldenburg, Lower Saxony, Germany

NOT_YET_RECRUITING

Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen

Outcomes

Primary Outcomes

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)

Time frame: 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)

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

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Central Contacts

Lars Wojtecki, Prof. Dr.

CONTACT

+492118106756 wojtecki@uni-duesseldorf.de

Data from ClinicalTrials.gov

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