NCT06470035

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 disorder(MDD) , 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 1:1 active to control allocation

Conditions

• Major Depressive Disorder \(MDD
• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	Active VeNS Device	Battery powered non-invasive neurostimulation device
DEVICE	Sham VeNS Device	Placebo comparator sham device (no active stimulation)

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-06-24
• Last updated: 2024-08-09

Locations

2 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study