German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
- Conditions
- Alzheimer Disease
- Interventions
- Diagnostic Test: Registry
- Registration Number
- NCT06313944
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Clinical Alzheimer's syndrome treated with TPS Registry 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
- Primary Outcome Measures
Name Time Method Number of (Serious) Adverse Events 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)
Number of adverse device effects 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 Outcome Measures
Name Time Method Mini Mental State Examination (MMSE) baseline and follow- up 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)
BDI-II 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)
Clinical Dementia Rating Sum of Boxes Score (CDR-SB) 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)
ADAS 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)
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 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)