NCT06620640

A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimer's Disease.

A Randomized, Double-blind, Experimental Study Evaluating the Efficiency and Safety for the VGuard Device in the Treatment of Alzheimer's Disease.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Neuromedical Sp. z o.o. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The project will allow the assessment of the safety and clinical effectiveness of the device for the treatment of cognitive impairment at Alzheimer\'s diease. The technology used in this study is based on the vagal nerve stimulation method used for more than 25 years and approved by the FDA in the treatment of drug-resistant epilepsy, depression and migraine. The study will use a non-invasive device for percutaneous electrostimulation of the vagal nerve. The previous clinical experience described in the literature has shown that vagal nerve stimulation leads to the activation of brain areas responsible for processing and consolidation of the fresh memory, i.e. the memory being impaired in so-called Alzheimer\'s Disease -AD. In relation to currently used methods of cognitive disorders treatment such as pharmacotherapy, the new solution will increase the effectiveness of therapy. In addition, VGuard is a completely non-invasive device that uses percutaneous stimulation, safe for the patient, and stimulation ranges are below the threshold of perception.

Conditions

• Alzheimer Disease (AD)

Interventions

Type	Name	Description
DEVICE	Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.	Nigth stimulation

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: Poland