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

NCT05845658 | Completed

• 1 other identifier: ICNAS001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of adverse events

  Up to 6 weeks

• Quality of life using SF-36 scores

  Up to 6 weeks

• Insomnia Severity Index (ISI) score

  Up to 6 weeks

Study Arms (2)

Active VeNS

ACTIVE COMPARATOR

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

Sham VeNS

SHAM COMPARATOR

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

Interventions

Active VeNS DEVICE

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.

Active VeNS

Sham VeNS DEVICE

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

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• R D Gardi Medical College, Ujjain: collaborator

Study Sites (1)

Department of Psychiatry of R.D. Gardi Medical College

Ujjain, Madhya Pradesh, 456001, India

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sai Sailesh Kumar Goothy

  R.D. Gardi Medical College, Ujjain, Madhya Pradesh.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: October 25, 2022
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)