Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313944
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
German Registry of Alzheimers Disease Treated With Transcranial Pulse Stimulation
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
German GE Multicenter Prospective Data Collection Registry on Treatment With Transcranial Pulse Wave Stimulation TPS in Patients With Alzheimers Disease A
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GE-R-A-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 Alzheimers 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 Alzheimers 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 Alzheimers symptoms as a result of TPS treatment is summarized in various neuropsychological scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None