Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620640
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Experimental Study Evaluating the Efficiency and Safety for the VGuard Device in the Treatment of Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CogniGuard
Brief Summary:
The project will allow the assessment of the safety and clinical effectiveness of the device for the treatment of cognitive impairment at Alzheimer39s 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 ie the memory being impaired in so-called Alzheimer39s 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None