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

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.

NCT Number	NCT06956105
Lead Sponsor	Neurovalens Ltd.
Conditions	General Anxiety Disorder
Enrollment	60 participants
Start Date	2025-09-08
Primary Completion	2026-06-13 (estimated)
Study Completion	2026-06-13 (estimated)
Updated on ClinicalTrials.gov	2026-07-01