Actively Recruiting
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
Led by Dr. Rafael Freire · Updated on 2025-04-08
10
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) criteria for generalized anxiety disorder.
- On a stable dose of selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 8 weeks.
- Treatment-resistant, defined as lack of response to at least two drugs from two different classes considered first-line or second-line for GAD, each trial lasting at least 8 weeks at minimum effective dose.
You will not qualify if you...
- Moderate to severe major depressive disorder.
- Moderate to high suicidality.
- Diagnosis of obsessive compulsive disorder, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities, dementia, or other neurological diseases including trigeminal neuralgia.
- Pregnant or breastfeeding women.
- Experiencing seizures.
- Implanted vagal nerve stimulation or other electrical devices.
- Already undergoing transcutaneous electrical nerve stimulation.
- Consumption of cannabis, cannabis by-products, illicit drugs, or alcohol above 3 drinks per week.
- Consumption of natural health products that may affect anxiety or depression symptoms.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Actively Recruiting
Research Team
Y
Yan Deng
CONTACT
R
Rafael Freire, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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