Recruiting

Trigeminal Nerve Stimulation

Sponsor:

Dr. Rafael Freire

Code:

NCT06278909

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Trigeminal Nerve Stimulation

Study Details

Brief 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

Study ID

NCT06278909

Start date

Jan 18, 2024

Status verified date

Apr, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active stimulation

Trigeminal nerve stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, New York, USA) bilaterally on the V1 branches of the trigeminal nerve (CNV) located on the forehead. Current will be generated from the EMS 7500 stimulator (TENS Products, Inc., Granby, CO) (Class II medical device) and will be set to a level that is clearly perceptible by each patient (i.e. tingling sensation) but not uncomfortable or painful. Current level will be determined for each patient at baseline and will likely be between 4-6 milliampere (mA). Active stimulation will occur at 120 Hz with a 250 μs pulse width and with a duty cycle of 30 seconds on to 30 seconds off.

Interventions

Trigeminal Nerve Stimulation

Active trigeminal nerve stimulation

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: Throughout the study, 8 weeks ]
  • Incidence of treatment-emergent side effects measured with the NSEC [ Time Frame: Baseline visit, 4-week visit and 8-week visit. ]
  • Response to treatment defined by CGI-I score below 3 [ Time Frame: 4-week visit and 8-week visit. ]

Central Contacts and Locations

Central contacts

Yan Deng

+1 613-548-7839yan.deng@queensu.ca

Rafael Freire, MD PhD

+1 613-548-7839rafael.freire@queensu.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada

Contacts

Yan Deng

+1-613-548-7839yan.deng@queensu.ca

Principal Investigator:

Rafael Freire, MD PhD

More Information

Sponsor

Dr. Rafael Freire

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Rafael Freire on 2025-04-08.