Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents
NCT ID: NCT06956105
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-08
2026-06-30
Brief Summary
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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.
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Detailed Description
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* Baseline: Study Visit 1 (0-week timepoint for enrolment)
* Study Visit 2 (2-week timepoint)
* End of Study (4-week timepoint)
* Post-intervention follow-up at 2 weeks (6-week timepoint)
* Post-intervention follow-up at 6 weeks (10-week timepoint)
* Post-intervention follow-up at 8 weeks (12-week timepoint)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active VeNS device
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.
Modius 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.
Sham device
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.
Sham 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.
Interventions
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Modius 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.
Sham 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.
Eligibility Criteria
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Inclusion Criteria
2. Signed Assent Form
3. Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
4. GAD-7 score of \>/=10 at screening
5. Can speak and read English
6. Ability and willingness to travel to the clinic to complete all study visits, stimulation sessions and procedures
7. Ability and willingness to adhere to 30 minutes usage of the device 5 days per week for the duration of the trial at clinic
8. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact anxiety e.g. dietary or exercise changes
Exclusion Criteria
2. Medication for anxiety
3. Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
4. Risk of persistent self-harm or suicide
5. Diagnosis or history of bipolar disorder
6. History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
7. Diagnosis of substance use disorder or dependence
8. Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
9. History of diagnosed cognitive impairment / disorder such as delirium or dementia
10. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
11. History of stroke or head injury requiring intensive care or neurosurgery
12. Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
13. History of epilepsy
14. History of severe tinnitus or vertigo
15. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
16. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
17. History of vestibular dysfunction or another inner ear disease
18. Regular use (more than twice a month) of antihistamine medication within the last 6 months
19. Diagnosis of active migraines
20. Previous use of Modius device or any VeNS device
21. Participation in other clinical trials sponsored by Neurovalens
22. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
23. Failure to use device daily during trial participation (no more than 7 consecutive days usage drop without reasonable explanation)
12 Years
17 Years
ALL
No
Sponsors
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Neurovalens Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sai Sailesh Kumar Goothy
Role: PRINCIPAL_INVESTIGATOR
BGS MCH Hospital
Locations
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BGS MCH Hospital
Bangalore, , India
Countries
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Central Contacts
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Facility Contacts
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Sai Sailesh
Role: primary
Other Identifiers
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NV-MC-2025-001
Identifier Type: -
Identifier Source: org_study_id
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