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

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Anxiety.

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Device: VeNS

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Hung Hom, Kowloon, Hong Kong
      • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Signed informed consent
2. Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent.
3. Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
4. Ability and willingness to complete all study visits and procedures
5. Agreement to engage with using the device on a daily basis
6. Agreement to engage with trial mentors
7. Agreement not to use prescription, or over the counter, anxiety medications for the duration of the trial
8. Access to Wi-Fi
9. Access to Apple smart phone (If not an Apple iPod will be supplied)

Exclusion Criteria

1. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
2. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
3. Use of beta-blockers within 1 month of starting the study
4. Use of antidepressants or unstable dose within 3 months of starting study
5. Medication for anxiety (unless regime stable for last 3 months).
6. 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).
7. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
8. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
9. History of epilepsy
10. History of active migraines with aura
11. History of head injury requiring intensive care or neurosurgery
12. History of cognitive impairment
13. History of of bipolar, psychotic or substance use disorders
14. Regular use (more than twice a month) of antihistamine medication within the last 6 months.
15. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
16. A diagnosis of myelofibrosis or a myelodysplastic syndrome.
17. Previous use of Modius device
18. Participation in other clinical trials sponsored by Neurovalens
19. Participation in any other anxiety studies
20. Have a member of the same household who is currently participating in this study.
21. Not fluent in English language

22. History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:

    • Do you have a history of any of the following?
    • Have you had hearing trouble?
    • Do you need hearing aids?
    • Have you had Ear Surgery resulting in hearing or balance loss?
    • Do you have Ear Pain?
    • Do you have tinnitus? (A ringing or buzzing in one or both ears)
    • Do you have dizziness?
    • Do you have trouble with balance?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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 1 hour per day.	Device: VeNS; 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 1 hour per day.
Sham Comparator: Sham; 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 1 hour per day.	Device: VeNS; 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 1 hour per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalised Anxiety Disorder (GAD-7) Scores	To evaluate the effect of the VeNS device, relative to control group on participants with anxiety (range 0-21) with higher score indicating more severe anxiety.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events.	4 weeks
Quality of life using SF-36 scores	To evaluate the effect of the VeNS device, relative to control group, on quality of life. SF-36 is a 36-item short form survey (range 0-100) with higher scores indicating a better quality of life.	4 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.	4 weeks

Collaborators and Investigators

• Sponsor: Neurovalens Ltd.
• Collaborators: Clinical Trial Mentors
• Investigators: Principal Investigator: Teris Cheung, PhD, Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: UUAS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No