Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation (NCT04931134)
Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (14 items).
Location: Kingston Health Sciences Centre — Kingston, Ontario
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Kingston Health Sciences Centre — Kingston, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.