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

NCT ID: NCT04333329

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-08
• Study Completion Date: 2017-02-15

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)

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AD Patients

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

Group Type: EXPERIMENTAL

NEUROLITH

Intervention Type: DEVICE

transcranial pulse stimulation (TPS)

Interventions

NEUROLITH

transcranial pulse stimulation (TPS)

Intervention Type: DEVICE

Other Intervention Names

transcranial pulse stimulation (TPS)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rheintalklinik

UNKNOWN

Sponsor Role: collaborator

Storz Medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henning Lohse-Busch, MD

Role: PRINCIPAL_INVESTIGATOR

Rheintalklinik

Locations

Rheintalklinik

Bad Krozingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

STU_14_032

Identifier Type: -

Identifier Source: org_study_id