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

Anxiety Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05845658
• Other study ID #: ICNAS001
• Status: Completed
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: June 10, 2023

Study information

• Verified date: January 2024
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• Active 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 30 minutes per day.
• Sham 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 30 minutes per day.

Locations

Country	Name	City	State
India	Department of Psychiatry of R.D. Gardi Medical College	Ujjain	Madhya Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Neurovalens Ltd.	R D Gardi Medical College, Ujjain

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of life using SF-36 scores		Up to 6 weeks
Secondary	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