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

NCT06956105 | Recruiting

• 1 other identifier: NV-MC-2025-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• The change in GAD-7 score from baseline to 4 weeks

  Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. GAD-7 has seven items, which measure severity of various signs of GAD according to reported response categories with assigned points. The GAD-7 items include: 1) nervousness; 2) inability to stop worrying; 3) excessive worry; 4) restlessness; 5) difficulty in relaxing; 6) easy irritation; and 7 fear of something awful happening. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was originally validated in a primary care sample and a cut-off score of 10 had a sensitivity value of 0.89 and a specificity value of 0.82 for identifying GAD.

  The GAD-7 shall be completed at baseline, 4 weeks (end of intervention) and 2 weeks, 6 weeks and 8 weeks post intervention .

Secondary Outcomes (3)

• Change in the Insomnia Severity Index (ISI) score from baseline to 4 weeks

  The ISI shall be completed at baseline and repeated at both 2 (mid-point) and 4 weeks (end of study).

• Change in the Mental Health-related Quality of Life (SF-36) mental component (MC) score from baseline to 4 weeks

  The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).

• Change in the Physical Health-related Quality of Life (SF-36) physical component (MC) score from baseline to 4 weeks.

  The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).

Study Arms (2)

Active VeNS device

EXPERIMENTAL

The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Device: Modius Calm

Sham device

SHAM COMPARATOR

The sham device looks identical to the active device. It will apply 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. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Device: Sham device

Interventions

Modius Calm DEVICE

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.

Active VeNS device

Sham device 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.

Sham device

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed Informed Consent
• Signed Assent Form
• Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
• GAD-7 score of \>/=10 at screening
• Can speak and read English
• Ability and willingness to travel to the clinic to complete all study visits, stimulation sessions and procedures
• Ability and willingness to adhere to 30 minutes usage of the device 5 days per week for the duration of the trial at clinic
• Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact anxiety e.g. dietary or exercise changes

You may not qualify if:

• GAD-7 score of \< 10 at screening
• Medication for anxiety
• Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
• Risk of persistent self-harm or suicide
• Diagnosis or history of bipolar disorder
• History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
• Diagnosis of substance use disorder or dependence
• Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
• History of diagnosed cognitive impairment / disorder such as delirium or dementia
• Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
• History of stroke or head injury requiring intensive care or neurosurgery
• Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
• History of epilepsy
• History of severe tinnitus or vertigo
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.

Sponsors & Collaborators

• Neurovalens Ltd.: lead

Study Sites (1)

BGS MCH Hospital

Bangalore, India

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sai Sailesh Kumar Goothy

  BGS MCH Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Reel

CONTACT

2890991835; trials@neurovalens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 2, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)