Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)

Storz Medical

Status: Completed

Conditions: Alzheimer Disease

Treatments: Device: NEUROLITH

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04333329

STU_14_032

Details and patient eligibility

About

This is a prospective open comprehensive proof-of-principle pilot study.

Full 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)

Enrollment: 15 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

AD Patients

Experimental group

Description:

All patients were treated with the TPS device (new name: NEUROLITH (Storz Medical AG)) - 6 sessions within 2 weeks, each sessions consisting of 6000 TPS pulses of 0.2 mJ/mm²

Treatment:

Device: NEUROLITH