RecruitingNot ApplicableNCT06956105

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents

A Randomized, Double-blind Sham-controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety in Adolescents - The Modius Calm Adolescent Study


Sponsor

Neurovalens Ltd.

Enrollment

60 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Trial title: A Randomized, Double-blind Sham-controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety in Adolescents - The Modius Calm Adolescent Study The aim of this study: This investigation aims to evaluate the effects of VeNS for the treatment of Generalized Anxiety Disorder, to contribute to the field of knowledge about the neurological mechanisms to determine whether the relatively inexpensive, and non-invasive technique of VeNS can reduce the severity of GAD symptoms in adolescents. 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.


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests a wearable device that delivers mild electrical stimulation to the inner ear (vestibular nerve stimulation) as a treatment for anxiety in teenagers. The device is worn like an earpiece and is non-invasive. Researchers want to know if this can reduce anxiety symptoms in adolescents with generalized anxiety disorder. **You may be eligible if...** - You are between 12 and 17 years old - You have a GAD-7 anxiety score of 10 or higher (indicating moderate to severe anxiety) - You can speak and read English - You are willing and able to come to the clinic 5 days per week for 30-minute device sessions during the trial - You are not currently taking any medication for anxiety **You may NOT be eligible if...** - Your anxiety score is below 10 (mild anxiety) - You are currently on medication for anxiety or recently started antidepressants - You have a diagnosis of bipolar disorder, psychosis, schizophrenia, or substance use disorder - You have a history of stroke, serious head injury, or implanted medical devices (such as a pacemaker) - You have a chronic viral infection such as hepatitis or HIV - You are at risk of self-harm or suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEModius Calm

The Modius Calm device is a transdermal neurostimulation product. It consists of a battery-powered headset designed to deliver low-level energy in the form of a neurostimulation waveform that modulates the activity of the vestibular cranial nerve. The active Modius Calm device utilizes a technology called electrical vestibular nerve stimulation (VeNS). In the envisaged configuration the device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current (a maximum of 1.5mA) to the skin behind the ears over the mastoid processes.

DEVICESham device

The sham device is identical in appearance. The Modius Calm sham device follows this pattern by applying some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device.


Locations(1)

BGS MCH Hospital

Bangalore, India

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NCT06956105


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