Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Generalized Anxiety Disorder Clinical Trial

Official title:

Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04931134
• Other study ID #: 6028648
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

Device:
• Trigeminal nerve stimulation - active
Active trigeminal nerve stimulation
• Trigeminal nerve stimulation - sham
Sham trigeminal nerve stimulation

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Rafael Freire

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	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.	Clinical Global Impression - Improvement scale (CGI-I) will be administered after 8 weeks of treatment.
Primary	Remission	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.	Clinical Global Impression - Severity scale (CGI-S) will be administered after 8 weeks of treatment.
Secondary	Generalized anxiety disorder symptoms	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).	Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.
Secondary	Social anxiety disorder symptoms	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).	Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment.
Secondary	Panic disorder symptoms	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).	Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment.
Secondary	Functioning	Improvement of functioning measured with the Sheehan Disability Scale (SDS). Scores go from 0 (no functional impairment) to 10 (severe functional impairment).	Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.
Secondary	Sustained response	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.	Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.
Secondary	Sustained remission	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.	Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment.