Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active stimulation 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
Active trigeminal nerve stimulation
|
| Sham Comparator: Sham stimulation 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
Sham trigeminal nerve stimulation
|
Outcome Measures
Primary Outcome Measures
- Response [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.
- Remission [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 Outcome Measures
- Generalized anxiety disorder symptoms [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).
- Social anxiety disorder symptoms [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).
- Panic disorder symptoms [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).
- Functioning [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).
- Sustained response [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.
- Sustained remission [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.
Exclusion Criteria:
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Subjects undergoing cognitive behavioural therapy.
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Subjects undergoing pharmacological treatment for an anxiety disorder.
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Subjects undergoing pharmacological treatment with antidepressants or benzodiazepines.
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Subjects with moderate to severe major depressive disorder based on the PHQ-9 test (score of 15 or above) at baseline.
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Moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder.
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Concurrent diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia.
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Subjects diagnosed with neurological diseases including trigeminal neuralgia.
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Pregnant or breastfeeding women.
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Subjects who are experiencing seizures.
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Individuals with implanted VNS or other electrical devices.
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Subjects who are already undergoing transcutaneous electrical nerve stimulation.
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Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week.
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Consumption of natural health products that may affect anxiety or depression symptoms.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kingston Health Sciences Centre | Kingston | Ontario | Canada |
Sponsors and Collaborators
- Dr. Rafael Freire
Investigators
- Principal Investigator: Rafael Freire, MD PhD, Department of Psychiatry, Queen's University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6028648