Actively Recruiting
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents
Led by Neurovalens Ltd. · Updated on 2026-01-06
60
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent form
- Male or female aged 12 to 17 years at consent
- GAD-7 score of 10 or higher at screening
- Ability to speak and read English
- Willingness and ability to travel to the clinic for all study visits and sessions
- Willingness to use the device for 30 minutes, 5 days per week at the clinic during the trial
- Agreement to avoid extreme lifestyle changes affecting anxiety during the study
You will not qualify if you...
- GAD-7 score below 10 at screening
- Current medication for anxiety or unstable antidepressant dose within 3 months
- Risk of persistent self-harm or suicide
- Diagnosis or history of bipolar disorder, psychotic disorders, or substance use disorder
- Use of recreational drugs without a 30-day washout
- History of cognitive impairment, chronic viral infection, stroke, or severe head injury
- Presence of implanted battery-powered medical devices
- History of epilepsy, severe tinnitus, vertigo, or dermatological conditions behind ears
- Recent malignancy except certain skin cancers
- Vestibular dysfunction or inner ear disease
- Frequent antihistamine use in last 6 months
- Active migraines
- Previous use of Modius or VeNS devices
- Participation in other Neurovalens trials
- Any condition or medication likely to reduce VeNS effectiveness
- Failure to use the device daily with no valid reason during the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
BGS MCH Hospital
Bangalore, India
Actively Recruiting
Research Team
J
Joe Reel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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