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

Neurovalens Ltd.1 site in 1 country60 target enrollmentOctober 25, 2022

ConditionsAnxiety

Overview

Phase: N/A
Intervention: Not specified
Conditions: Anxiety
Sponsor: Neurovalens Ltd.
Enrollment: 60
Locations: 1
Primary Endpoint: Generalised Anxiety Disorder (GAD-7) Scores
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study will be conducted at the Department of Physiology in collaboration with the Department of Psychiatry of R.D. Gardi Medical College, Ujjain, Madhya Pradesh.

This double-blind randomized controlled trial will remotely enroll 60 subjects. Each participant will complete 20 stimulation sessions at a rate of 3-5 sessions per week. Each session will be 30 minutes on the day of usage. The study will be randomized with a 1:1 active; or sham control allocation. Endpoint analysis will be performed upon completion of the study.

Registry

clinicaltrials.gov

Start Date

October 25, 2022

End Date

June 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neurovalens Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
•Males or females 18-80 years of age inclusive on starting the study
•Can speak/read English
•Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis
•Not using, and have never used, prescription, or the counter, anxiety medications
•Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes

Exclusion Criteria

•History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
•Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent the Modius Stress device from working)
•Medication for anxiety
•Use of beta-blockers within 1 month of starting the study
•Use of antidepressants or unstable dose within 3 months of starting study
•Use of any other medical condition or medication use that in the opinion of the PI is likely to make the participant resistant to VeNS.
•A score higher than 14 on the Insomnia Severity Index (ISI)
•A history of stroke or severe head injury (as defined by a head injury that required a craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
•Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.).
•Pregnancy or breast-feeding or intends to become pregnant (a pregnancy kit can be mailed if any uncertainty)