Clinical trial NCT05845658: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety: A Randomized 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: R D Gardi Medical College, Ujjain
First posted: 2023-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* 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

Primary outcomes:
measure: Generalised Anxiety Disorder (GAD-7) Scores
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Number of adverse events
timeFrame: Up to 6 weeks
measure: Quality of life using SF-36 scores
timeFrame: Up to 6 weeks
measure: Insomnia Severity Index (ISI) score
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Ujjain
country: India
facility: Department of Psychiatry of R.D. Gardi Medical College
state: Madhya Pradesh
Study officials:
affiliation: R.D. Gardi Medical College, Ujjain, Madhya Pradesh.
name: Sai Sailesh Kumar Goothy
role: PRINCIPAL_INVESTIGATOR
References: