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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06313944
Study type Observational
Source Heinrich-Heine University, Duesseldorf
Contact Lars Wojtecki, Prof. Dr.
Phone +492118106756
Email wojtecki@uni-duesseldorf.de
Status Not yet recruiting
Phase
Start date April 1, 2024
Completion date October 1, 2026

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