RecruitingNot ApplicableNCT06278909

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


Sponsor

Dr. Rafael Freire

Enrollment

10 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study is testing a non-invasive brain stimulation technique called trigeminal nerve stimulation (TNS) — delivered through a small device worn on the forehead — for people with treatment-resistant generalized anxiety disorder (GAD) who have not responded to at least two different anxiety medications. **You may be eligible if...** - You have a confirmed diagnosis of generalized anxiety disorder (GAD) - You have not responded to at least two different anxiety medications (from different drug classes, taken at adequate doses for at least 8 weeks each) - You are currently on a stable dose of an SSRI or SNRI antidepressant for at least 8 weeks **You may NOT be eligible if...** - You have moderate to severe major depression or significant suicidal thoughts - You have OCD, PTSD, bipolar disorder, schizophrenia, personality disorders, intellectual disability, dementia, or other neurological conditions - You are pregnant or breastfeeding - You have a seizure disorder - You have a vagus nerve stimulator or other electrical implant - You currently use cannabis, illicit drugs, or drink more than 3 alcoholic beverages per week Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETrigeminal Nerve Stimulation

Active trigeminal nerve stimulation


Locations(1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

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NCT06278909


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