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

RecruitingNAAges 18 Years - 65 YearsAllDr. Rafael Freire
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Trigeminal Nerve Stimulation
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Where

1 site
Kingston Health Sciences Centre
Kingston, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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