Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-14
Brief Title:
Electrical Vestibular Nerve Stimulation VeNS as a Treatment for Major Depressive Disorder MDD
Sponsor:
Neurovalens Ltd
Organization:
Neurovalens Ltd
Study Overview
Official Title:
A Randomized Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation VeNS Compared to a Sham Control for Treatment of Major Depressive Disorder MDD - Modius Mood Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Trial title A Randomized Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation VeNS Compared to a Sham Control for Treatment of Major Depressive Disorder MDD - Modius Mood Study
The aim of this study To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation VeNS as a method of treating major depressive disorderMDD as compared to a sham control
Allocation Randomized to either active device or control device usage
Endpoint classification Efficacy Study Intervention Model Parallel Assignment in 11 active to control allocation
The aim of this study To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation VeNS as a method of treating major depressive disorderMDD as compared to a sham control
Allocation Randomized to either active device or control device usage
Endpoint classification Efficacy Study Intervention Model Parallel Assignment in 11 active to control allocation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None