Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT06956105
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent
2. Signed Assent Form
3. Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
4. GAD-7 score of \>/=10 at screening
5. Can speak and read English
6. Ability and willingness to travel to the clinic to complete all study visits, stimulation sessions and procedures
7. Ability and willingness to adhere to 30 minutes usage of the device 5 days per week for the duration of the trial at clinic
8. 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:
1. GAD-7 score of \< 10 at screening
2. Medication for anxiety
3. Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
4. Risk of persistent self-harm or suicide
5. Diagnosis or history of bipolar disorder
6. History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
7. Diagnosis of substance use disorder or dependence
8. Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
9. History of diagnosed cognitive impairment / disorder such as delirium or dementia
10. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
11. History of stroke or head injury requiring intensive care or neurosurgery
12. Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
13. History of epilepsy
14. History of severe tinnitus or vertigo
15. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
16. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
17. History of vestibular dysfunction or another inner ear disease
18. Regular use (more than twice a month) of antihistamine medication within the last 6 months
19. Diagnosis of active migraines
20. Previous use of Modius device or any VeNS device
21. Participation in other clinical trials sponsored by Neurovalens
22. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
23. Failure to use device daily during trial participation (no more than 7 consecutive days usage drop without reasonable explanation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT06956105
Study Brief:
Protocol Section:
NCT06956105