Brain Stimulation for Neurological Patients

Storz Medical

Status: Completed

Conditions: Alzheimer Disease

Treatments: Device: NEUROLITH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03770182

TPS-AD-Vienna

Details and patient eligibility

About

This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
• At least 3 months of stable antidementive therapy or no antidementive therapy necessary
• Signed written informed consent
• Monthly pregnancy test for women in childbearing years
• Age >= 18 years

Exclusion criteria

• Non-compliance with the protocol
• Pregnant or breastfeeding women
• Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
• Hemophilia or other blood clotting disorders
• Cortisone treatment within the last 6 weeks before first treatment
• Thrombosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group A

Experimental group

Description:

NEUROLITH * Cycle 1: Active treatment * Cycle 2: Sham treatment

Treatment:

Device: NEUROLITH

Group B

Experimental group

Description:

NEUROLITH * Cycle 1: Sham treatment * Cycle 2: Active treatment

Treatment:

Device: NEUROLITH