Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial

Primary objectives: The primary objective is to ascertain if trigeminal nerve stimulation is an effective treatment with high tolerability for patients with panic disorder, generalized anxiety disorder and social anxiety disorder.

Inclusion Criteria:

• Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.

Exclusion Criteria:

• Subjects undergoing cognitive behavioural therapy.
• Subjects undergoing pharmacological treatment for an anxiety disorder.
• Subjects undergoing pharmacological treatment with antidepressants or benzodiazepines.
• Subjects with moderate to severe major depressive disorder based on the PHQ-9 test (score of 15 or above) at baseline.
• Moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder.
• Concurrent diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia.
• Subjects diagnosed with neurological diseases including trigeminal neuralgia.
• Pregnant or breastfeeding women.
• Subjects who are experiencing seizures.
• Individuals with implanted VNS or other electrical devices.
• Subjects who are already undergoing transcutaneous electrical nerve stimulation.
• Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week.
• Consumption of natural health products that may affect anxiety or depression symptoms.