Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

NCT04931134 | Active Not Recruiting FDA Device

• 1 other identifier: 6028648
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (6)

• Generalized anxiety disorder symptoms

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

• Social anxiety disorder symptoms

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

• Panic disorder symptoms

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

• Functioning

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

• Sustained response

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

Study Arms (2)

Active stimulation

EXPERIMENTAL

Active or sham TNS treatment will be performed at the patients' home for approximately 8 hours per night 7 days a week for 8 consecutive weeks. Trigeminal nerve stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, NY, 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 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.

Device: Trigeminal nerve stimulation - active

Sham stimulation

SHAM COMPARATOR

Active or sham TNS treatment will be performed at the patients' home for approximately 8 hours per night 7 days a week for 8 consecutive weeks. Sham stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, NY, 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 mA. Sham stimulation will use the same parameters of active stimulation, but after 60 seconds the stimulator will turn off.

Device: Trigeminal nerve stimulation - sham

Interventions

Trigeminal nerve stimulation - active DEVICE

Active trigeminal nerve stimulation

Active stimulation

Trigeminal nerve stimulation - sham DEVICE

Sham trigeminal nerve stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Rafael Freire: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

MeSH Terms

Conditions

Panic Disorder; Generalized Anxiety Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Rafael Freire, MD PhD

  Department of Psychiatry, Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham stimulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: February 7, 2022
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)