Clinical trial NCT06313944: German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
Official title: German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Transcranial Pulse Wave Stimulation (TPS)
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Storz Medical AG
First posted: 2024-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AD Patients undergoing TPS

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of (Serious) Adverse Events
timeFrame: through study completion, an average of 1 year
measure: Number of adverse device effects
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: ADAS
timeFrame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
measure: Mini Mental State Examination (MMSE) baseline and follow- up
timeFrame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
measure: BDI-II
timeFrame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
measure: Clinical Dementia Rating Sum of Boxes Score (CDR-SB)
timeFrame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
measure: Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL)
timeFrame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Other outcomes:
measure: Numeric Rating Scale (NRS) for the main symptom
timeFrame: 12 months
Locations:
city: Kempen
country: Germany
facility: Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
city: Ulm
country: Germany
facility: Praxis Dr. Schwarz
Study officials:
affiliation: Heinrich-Heine-Universität
name: Lars Wojtecki, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: