NCT06278909

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Dr. Rafael Freire · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DEVICE	Trigeminal Nerve Stimulation	Active trigeminal nerve stimulation

Timeline

• Start date: 2024-01-18
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2024-02-26
• Last updated: 2025-04-08

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study