NCT05907967

Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety

Completed NA Last updated 16 January 2024

What this trial tests

NA trial testing VeNS in Anxiety in 83 participants. Completed in 20 April 2023.

Timeline

18 July 2022

Primary endpoint
20 April 2023

20 April 2023

Quick facts

Lead sponsor	Neurovalens Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	83
Start date	18 July 2022
Primary completion	20 April 2023
Estimated completion	20 April 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• VeNS

Conditions studied

• Anxiety — all drugs for Anxiety →

Sponsor

Neurovalens Ltd.

Who can join

Adults 18 to 80, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Anxiety is known to be one of the most common health concerns in in the general population, and the most common mental health issue, and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and anxiety continues to be explored, however its usefulness in the treatment of anxiety is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of anxiety, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. It also could present an alternative intervention for patients who are non-responsive or refuse medication. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with anxiety.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Repeated Electrical Vestibular Nerve Stimulation Reduces Anxiety in People With Moderate-to-Severe Anxiety: A Randomized, Sham-Controlled Trial: The Modius Anxiety Study.
   Curry G, Zhang SD, McAnena L, Price RK, et al · · 2026 · PMID 41642155 · DOI 10.1016/j.neurom.2025.11.008