NCT06278909 Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
| NCT ID | NCT06278909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Rafael Freire |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-01-18 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD). * The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD. * The secondary objective will be to monitor changes in GAD symptom severity throughout the study. Results from this study will inform a randomized controlled trial to be conducted in the future.
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
Contact & Investigator
Rafael Freire, MD PhD
PRINCIPAL INVESTIGATOR
Department of Psychiatry, Queen's University
Frequently Asked Questions
Who can join the NCT06278909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06278909 currently recruiting?
Yes, NCT06278909 is actively recruiting participants. Contact the research team at yan.deng@queensu.ca for enrollment information.
Where is the NCT06278909 trial being conducted?
This trial is being conducted at Kingston, Canada.
Who is sponsoring the NCT06278909 clinical trial?
NCT06278909 is sponsored by Dr. Rafael Freire. The principal investigator is Rafael Freire, MD PhD at Department of Psychiatry, Queen's University. The trial plans to enroll 10 participants.
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