Back to resultsTreatment of Anxiety Disorders With Trigeminal Nerve Stimulation
Primary Purpose
Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Trigeminal nerve stimulation - active
Trigeminal nerve stimulation - sham
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
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.
Sites / Locations
- Kingston Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active stimulation
Sham stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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).
Functioning
Improvement of functioning measured with the Sheehan Disability Scale (SDS). Scores go from 0 (no functional impairment) to 10 (severe functional impairment).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04931134
Brief Title
Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation
Official Title
Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Rafael Freire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sham stimulation
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Trigeminal nerve stimulation - active
Intervention Description
Active trigeminal nerve stimulation
Intervention Type
Device
Intervention Name(s)
Trigeminal nerve stimulation - sham
Intervention Description
Sham trigeminal nerve stimulation
Primary Outcome Measure Information:
Title
Response
Description
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.
Time Frame
Clinical Global Impression - Improvement scale (CGI-I) will be administered after 8 weeks of treatment.
Title
Remission
Description
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.
Time Frame
Clinical Global Impression - Severity scale (CGI-S) will be administered after 8 weeks of treatment.
Secondary Outcome Measure Information:
Title
Generalized anxiety disorder symptoms
Description
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).
Time Frame
Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.
Title
Social anxiety disorder symptoms
Description
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).
Time Frame
Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment.
Title
Panic disorder symptoms
Description
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).
Time Frame
Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment.
Title
Functioning
Description
Improvement of functioning measured with the Sheehan Disability Scale (SDS). Scores go from 0 (no functional impairment) to 10 (severe functional impairment).
Time Frame
Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.
Title
Sustained response
Description
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.
Time Frame
Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.
Title
Sustained remission
Description
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.
Time Frame
Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Deng
Phone
+1 613-548-3232
Email
yan.deng@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Freire, MD PhD
Organizational Affiliation
Department of Psychiatry, Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Deng
Phone
+1-613-548-3232
Email
yan.deng@queensu.ca
First Name & Middle Initial & Last Name & Degree
Rafael Freire, MD PhD
First Name & Middle Initial & Last Name & Degree
Elisa Brietzke, MD PhD
First Name & Middle Initial & Last Name & Degree
Claudio Soares, MD PhD
First Name & Middle Initial & Last Name & Degree
Roumen Milev, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation
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