Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety

Inclusion criteria

• Signed informed consent
• Male or female, age ≥ 18 years and ≤ 80 years at the time of signing 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)
• Ability and willingness to complete all study visits and procedures
• Agreement to engage with using the device on a daily basis
• Agreement to engage with trial mentors
• Agreement not to use prescription, or over the counter, anxiety medications for the duration of the trial
• Access to Wi-Fi
• Access to Apple smart phone (If not an Apple iPod will be supplied)

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 VeNS from working)
• Use of beta-blockers within 1 month of starting the study
• Use of antidepressants or unstable dose within 3 months of starting study
• Medication for anxiety (unless regime stable for last 3 months).
• 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.).
• 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)
• History of epilepsy
• History of active migraines with aura
• History of head injury requiring intensive care or neurosurgery
• History of cognitive impairment
• History of of bipolar, psychotic or substance use disorders
• 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 a myelodysplastic syndrome.
• Previous use of Modius device
• Participation in other clinical trials sponsored by Neurovalens
• Participation in any other anxiety studies
• Have a member of the same household who is currently participating in this study.
• Not fluent in English language
• History of vestibular dysfunction or other inner ear disease