Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents

This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the BGS MCH Hospital. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the clinic. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:

• Baseline: Study Visit 1 (0-week timepoint for enrolment)
• Study Visit 2 (2-week timepoint)
• End of Study (4-week timepoint)
• Post-intervention follow-up at 2 weeks (6-week timepoint)
• Post-intervention follow-up at 6 weeks (10-week timepoint)
• Post-intervention follow-up at 8 weeks (12-week timepoint)

Inclusion criteria

• Signed Informed Consent
• Signed Assent Form
• Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
• GAD-7 score of >/=10 at screening
• Can speak and read English
• Ability and willingness to travel to the clinic to complete all study visits, stimulation sessions and procedures
• Ability and willingness to adhere to 30 minutes usage of the device 5 days per week for the duration of the trial at clinic
• Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact anxiety e.g. dietary or exercise changes

Exclusion criteria

• GAD-7 score of < 10 at screening
• Medication for anxiety
• Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
• Risk of persistent self-harm or suicide
• Diagnosis or history of bipolar disorder
• History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
• Diagnosis of substance use disorder or dependence
• Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
• History of diagnosed cognitive impairment / disorder such as delirium or dementia
• Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
• History of stroke or head injury requiring intensive care or neurosurgery
• Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
• History of epilepsy
• History of severe tinnitus or vertigo
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
• History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
• History of vestibular dysfunction or another inner ear disease
• Regular use (more than twice a month) of antihistamine medication within the last 6 months
• Diagnosis of active migraines
• Previous use of Modius device or any VeNS device
• Participation in other clinical trials sponsored by Neurovalens
• Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
• Failure to use device daily during trial participation (no more than 7 consecutive days usage drop without reasonable explanation)