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

NCT06051864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Modius Mood Active Device

Battery powered non-invasive neurostimulation device

DEVICE

Sham Device

Placebo comparator sham device (no active stimulation)

Sponsors & Collaborators

  • NRI Institute of Medical Sciences

    collaborator UNKNOWN

  • Neurovalens Ltd.

    lead INDUSTRY

Principal Investigators

  • Sai Sailesh Kumar Goothy · NRI Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-03
Primary Completion
2024-11-05
Completion
2024-11-05

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051864 on ClinicalTrials.gov