Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study

Launched by DR. RAFAEL FREIRE · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option called trigeminal nerve stimulation (TNS) for people with generalized anxiety disorder (GAD) who have not found relief from traditional medications. Over 8 weeks, ten participants will receive TNS while continuing their regular anxiety medication. The main goal is to see if TNS is safe and well-tolerated, and researchers will also track any changes in anxiety symptoms during this time.

To join the study, participants need to have a diagnosis of GAD and have been on a stable dose of specific medications for at least 8 weeks without improvement. However, those with certain other mental health conditions, high risk of self-harm, or who are currently pregnant or using other electrical stimulation devices are not eligible. This study is an initial step, and its results will help plan a larger trial in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) criteria for generalized anxiety disorder.
• • Subjects on a stable dose of an selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 8 weeks.
• • Treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD. Only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials.
• Exclusion Criteria:
• • Moderate to severe major depressive disorder
• • Moderate to high suicidality
• • Diagnosis of obsessive compulsive disorder (OCD), PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia
• • Pregnant or breastfeeding women
• • Participants who are experiencing seizures
• • Implanted vagal nerve stimulation (VNS) or other electrical devices
• • Participants 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