Trials / Recruiting
RecruitingNCT06313944
German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Heinrich-Heine University, Duesseldorf · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Registry | Clinical data collection of patients scheduled for on-label treatment |
Timeline
- Start date
- 2025-08-06
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2024-03-15
- Last updated
- 2025-11-26
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06313944. Inclusion in this directory is not an endorsement.