Status:
COMPLETED
Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)
Lead Sponsor:
Storz Medical AG
Collaborating Sponsors:
Rheintalklinik
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a prospective open comprehensive proof-of-principle pilot study.
Detailed Description
This is a prospective open comprehensive proof-of-principle pilot study with patients of mild to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation (TPS)
Eligibility Criteria
Inclusion
- Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
- MMSE ≥ 10: Mild and moderate Alzheimer's Disease according to AWMF Register, S3 Guidelines of DGN 038/013 and DEGAM 035/021
- At least 3 months of stable antidementia therapy or no antidementia therapy necessary (Patients need to continue their standard treatment within the clinical investigation according to the guidelines as TPS is considered an additional treatment to standard therapy)
- Signed written informed consent
- 18 years ≤ Age ≤ 85 years
- Monthly pregnancy tests for female patients in childbearing age
Exclusion
- Non-compliance with the protocol (including CERAD-plus)
- Pregnancy
- Breast-feeding women
- Microbubbles (contrast agents) in application area
- Cerebral pathology unrelated to Alzheimer's disease
- Metallic objects in the head
- Neurosurgical intervention of the brain / Craniotomy
- Cardiac disorders
- History of psychiatric diseases before development of dementia
- Hemophilia or other blood clotting disorders
- Cortisone treatment up to 6 months before first treatment
- Other conditions implying increased risk according to the judgement of the investigator
Key Trial Info
Start Date :
August 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04333329
Start Date
August 8 2015
End Date
February 15 2017
Last Update
April 3 2020
Active Locations (1)
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1
Rheintalklinik
Bad Krozingen, Baden-Wurttemberg, Germany, 79189