Electrical vestibular stimulation (VeNS) to reduce 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

This trial will try a gentle, non-invasive electrical vestibular stimulation device called Modius Calm to see if it reduces anxiety in adolescents aged 12–17 with moderate to severe generalized anxiety.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Neurovalens Ltd. (industry)
• Locations: 1 site (Bangalore)
• Trial ID: NCT06956105 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, sham-controlled parallel trial enrolling up to 60 adolescents at BGS MCH Hospital in Bangalore. Participants are randomized 1:1 to receive either active Modius Calm VeNS or a sham device and complete supervised 30-minute stimulation sessions five days per week during the intervention period. The randomized intervention period is eight weeks, with study visits at baseline, 2 weeks, 4 weeks, and follow-up visits extending to a total 12-week participation timeline. Outcomes will compare changes in anxiety symptom severity between active and sham groups.

Who should consider this trial

Good fit: Adolescents aged 12–17 with a GAD-7 score of 10 or higher who can read English, provide consent/assent, travel to the clinic, and are not taking anxiety medications would be ideal candidates.

Not a fit: Those with GAD-7 scores below 10, current anxiety medication use, bipolar disorder, psychosis, active suicidal risk, or who cannot attend frequent clinic sessions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, VeNS could offer a low-cost, non-drug option to lower anxiety symptoms in teenagers.

How similar studies have performed: Small adult and pilot studies of vestibular stimulation have reported reductions in anxiety symptoms, but randomized sham-controlled evidence in adolescents is limited, making this a relatively novel application.

Eligibility criteria

Inclusion Criteria:

1. Signed Informed Consent
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:

1. GAD-7 score of \< 10 at screening
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)

Where this trial is running

Bangalore

• BGS MCH Hospital — Bangalore, India (RECRUITING)

Study contacts

• Principal investigator: Sai Sailesh Kumar Goothy — BGS MCH Hospital
• Study coordinator: Joe Reel

Conditions: General Anxiety Disorder