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

NCT06278909 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-08

No results posted yet for this study

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

DEVICE

Trigeminal Nerve Stimulation

Active trigeminal nerve stimulation

Sponsors & Collaborators

  • Dr. Rafael Freire

    lead OTHER

Principal Investigators

  • Rafael Freire, MD PhD · Department of Psychiatry, Queen's University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2026-03-01
Completion
2026-04-01
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06278909 on ClinicalTrials.gov