Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety: A Randomized Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anxiety

Intervention / Treatment
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* Device: Active VeNS
* Device: Sham VeNS


Participation Criteria
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Eligibility Criteria
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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) History of epilepsy History of active migraines with aura History of head injury requiring intensive care or neurosurgery History of diagnosed cognitive impairment such as Alzheimer's disease/dementia History of bipolar, psychotic or substance use disorders Diagnosis of a current psychotic disorder Regular use (more than twice a month) of antihistamine medication within the last 6 months. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas) A diagnosis of myelofibrosis or myelodysplastic syndrome. Previous use of any VeNS device Participation in other clinical trials History of vestibular dysfunction or another inner ear disease

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active VeNS<br>The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day. | Device: Active VeNS<br>* The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.<br>|
| Sham Comparator: Sham VeNS<br>The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day. | Device: Sham VeNS<br>* The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalised Anxiety Disorder (GAD-7) Scores | To evaluate the ability of the Modius Stress device, relative to the control group, in the management of anxiety. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | To evaluate the safety of the VeNS device relative to control group, in terms of the occurrence of adverse events. | Up to 6 weeks | 
| Quality of life using SF-36 scores |  | Up to 6 weeks | 
| Insomnia Severity Index (ISI) score | To evaluate the effect of the VeNS device, relative to control group on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia. | Up to 6 weeks |