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NCT Number: NCT04931134

Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Primary objectives: The primary objective is to ascertain if trigeminal nerve stimulation is an effective treatment with high tolerability for patients with panic disorder, generalized anxiety disorder and social anxiety disorder.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Panic Disorder Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.

Exclusion criteria

  • Subjects undergoing cognitive behavioural therapy.
  • Subjects undergoing pharmacological treatment for an anxiety disorder.
  • Subjects undergoing pharmacological treatment with antidepressants or benzodiazepines.
  • Subjects with moderate to severe major depressive disorder based on the PHQ-9 test (score of 15 or above) at baseline.
  • Moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder.
  • Concurrent diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia.
  • Subjects diagnosed with neurological diseases including trigeminal neuralgia.
  • Pregnant or breastfeeding women.
  • Subjects who are experiencing seizures.
  • Individuals with implanted VNS or other electrical devices.
  • Subjects 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 - active

Device

Active trigeminal nerve stimulation

Trigeminal nerve stimulation - sham

Device

Sham trigeminal nerve stimulation

Primary outcomes

  1. Response

    Time frame: Clinical Global Impression - Improvement scale (CGI-I) will be administered after 8 weeks of treatment.

    Treatment response will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement scale (CGI-I). CGI-I scores range from 0 to 7. Zero corresponds to "not assessed". Low scores correspond to improvement, high scores correspond to worsening.

  2. Remission

    Time frame: Clinical Global Impression - Severity scale (CGI-S) will be administered after 8 weeks of treatment.

    Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity scale (CGI-S). CGI-S scores range from 0 to 7. Zero corresponds to "not assessed". Low scores correspond to mild and high scores correspond to severe.

Secondary outcomes

  1. Generalized anxiety disorder symptoms

    Time frame: Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.

    Improvement of generalized anxiety disorder symptoms measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores go from 0 (no generalized anxiety symptoms) to 21 (severe generalized anxiety symptoms).

  2. Social anxiety disorder symptoms

    Time frame: Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment.

    Improvement of social anxiety disorder symptoms measured with the Social Phobia Inventory (SPIN). Scores go from 0 (no social anxiety symptoms) to 68 (severe social anxiety symptoms).

  3. Panic disorder symptoms

    Time frame: Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment.

    Improvement of panic disorder symptoms measured with the Panic Disorder Severity Scale - Self Report version (PDSS-SR). Scores go from 0 (no panic symptoms) to 4 (severe panic symptoms).

  4. Functioning

    Time frame: Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.

    Improvement of functioning measured with the Sheehan Disability Scale (SDS). Scores go from 0 (no functional impairment) to 10 (severe functional impairment).

  5. Sustained response

    Time frame: Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.

    Treatment response will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement scale (CGI-I).

    CGI-I scores range from 0 to 7. Zero corresponds to "not assessed". Low scores correspond to improvement, high scores correspond to worsening.

  6. Sustained remission

    Time frame: Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment.

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

    CGI-S scores range from 0 to 7. Zero corresponds to "not assessed". Low scores correspond to mild and high scores correspond to severe.

Sponsors and collaborators

Lead sponsor

Dr. Rafael Freire

Other

Registry information

Official study title

Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 18, 2021
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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