Trigeminal nerve stimulation for treatment-resistant anxiety
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
This study is testing if trigeminal nerve stimulation can help people with treatment-resistant anxiety feel better while they continue their usual medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06278909 on ClinicalTrials.gov |
What this trial studies
This feasibility study investigates the use of trigeminal nerve stimulation (TNS) as an additional treatment for patients with treatment-resistant generalized anxiety disorder (TR-GAD). Over the course of 8 weeks, ten participants will receive TNS while continuing their pharmacological treatment. The primary goal is to evaluate the safety and tolerability of TNS, while secondary objectives include monitoring changes in anxiety symptom severity. The findings will help inform future randomized controlled trials.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with generalized anxiety disorder who have not responded to at least two different classes of first-line or second-line medications.
Not a fit: Patients with moderate to severe major depressive disorder or other specified psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with treatment-resistant generalized anxiety disorder.
How similar studies have performed: While this approach is novel, similar studies exploring non-pharmacological interventions for anxiety have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kingston, Ontario
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Rafael Freire, MD PhD — Department of Psychiatry, Queen's University
- Study coordinator: Yan Deng
- Email: yan.deng@queensu.ca
- Phone: +1 613-548-7839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.