NCT06051864

Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for Depression

Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating Depression, 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 Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.

Detailed description

This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the NRI Institute of Medical Sciences. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the Department of Physiology. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints: * Baseline: Study Visit 1 (0-week timepoint for enrolment) * Study Visit 2 (2-week timepoint) * Study Visit 3 (4-week timepoint) * Study Visit 4 (6-week timepoint) * End of Study: Study Visit 5 (8-week timepoint) * Post-intervention follow-up at 4 weeks (12-week timepoint)

Conditions

• Depression

Interventions

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

Timeline

• Start date: 2023-12-03
• Primary completion: 2024-11-05
• Completion: 2024-11-05
• First posted: 2023-09-25
• Last updated: 2024-12-20

Locations

1 site across 1 country: India