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

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