Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)

Exclusion Criteria

• •1. Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)
• •2. Diagnosis or history of bipolar disorder
• •3. History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
• •4. Diagnosis of substance use disorder within the past 12 months or current substance use dependence
• •5. Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
• •6. Female who is pregnant or breast-feeding
• •7. History of diagnosed cognitive impairment / disorder such as delirium or dementia
• •8. Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy).
• •9. History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation)
• •10. Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
• •11. History of epilepsy
• •12. History of severe tinnitus or vertigo
• •13. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
• •14. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
• •15. History of vestibular dysfunction or another inner ear disease
• •16. Regular use (more than twice a month) of antihistamine medication within the last 6 months. The subject can opt to switch to Fexofenadine (non-drowsy) and may enrol after a wash-out period of 2 weeks
• •17. Diagnosis of active migraines
• •18. Previous use of Modius device or any VeNS device
• •19. Participation in other clinical trials sponsored by Neurovalens
• •20. Participation in any other depression studies at the time of enrolment and throughout this study duration
• •21. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
• •22. Failure to use device daily during trial participation (no more than 14 consecutive days usage drop without reasonable explanation)
• •23. Persistent failure to comply with study protocol and procedures