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NCT Number: NCT06278909

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

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location status: Recruiting

Location contact

Claudio Soares, MD PhD

SUB_INVESTIGATOR

Elisa Brietzke, MD PhD

SUB_INVESTIGATOR

Rafael Freire, MD PhD

PRINCIPAL_INVESTIGATOR

Yan Deng

CONTACT

[email protected]

+1-613-548-7839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trigeminal Nerve Stimulation

Device

Active trigeminal nerve stimulation

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: Throughout the study, 8 weeks

    Monitor participants for treatment-emergent adverse events and serious adverse events.

  2. Incidence of treatment-emergent side effects measured with the NSEC

    Time frame: Baseline visit, 4-week visit and 8-week visit.

    Monitor participants for minor treatment-emergent side effects measured with the Neurostimulation Side-Effect Checklist (NSEC).

    NSEC is a list of 31 possible side effects from neurostimulation or from antidepressants. Each item is rated from 0 (absent) to 3 (severe).

  3. Response to treatment defined by CGI-I score below 3

    Time frame: 4-week visit and 8-week visit.

    Response to treatment, which will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement (CGI-I) scale.

    CGI-I is a clinician administered one-item clinical scale rated from 1 (very much improved) to 7 (very much worse). Not assessed would confer score 0.

Secondary outcomes

  1. Remission defined by CGI-S score below 3

    Time frame: 4-week visit and 8-week visit.

    Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity (CGI-S) scale.

    CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0.

  2. Change in anxiety severity measured by CGI-S

    Time frame: Baseline visit, 4-week visit and 8-week visit.

    Changes in scores for CGI-S by comparing the scores in each visit. CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0.

  3. Change of anxiety symptoms measured with GAD-7

    Time frame: Baseline visit, 4-week visit and 8-week visit.

    Changes in scores for Generalized Anxiety Disorder 7-item scale (GAD-7) by comparing the scores in each visit.

    GAD-7 is a self-rated 7-item scale, each item is rated from 0 (not at all) to 3 (nearly every day).

  4. Change of anxiety symptoms measured with PSWQ

    Time frame: Baseline visit, 4-week visit and 8-week visit.

    Changes in scores for Penn State Worry Questionnaire (PSWQ) by comparing the scores in each visit.

    PSWQ is a self-rated 16-item scale, each item is rated from 1 (not at all typical of me) to 5 (very typical of me).

  5. Change of anxiety symptoms measured with BAI

    Time frame: Baseline visit, 4-week visit and 8-week visit.

    Changes in scores for Beck Anxiety Inventory (BAI) by comparing the scores in each visit.

    BAI is a self-rated 21-item scale, each item is rated from 0 (not at all) to 3 (severely - it bothered me a lot).

Study contacts

Contact information is provided by the study sponsor or research team.

Rafael Freire, MD PhD

CONTACT

[email protected]

+1 613-548-7839

Yan Deng

CONTACT

[email protected]

+1 613-548-7839

Sponsors and collaborators

Lead sponsor

Dr. Rafael Freire

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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