Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Remission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sham stimulation
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Sustained remission(Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the 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.)
- Sustained response(Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.)
- Generalized anxiety disorder symptoms(Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.)
- Functioning(Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.)
Investigators
Dr. Rafael Freire
Associate Professor, Department of Psychiatry
Kingston Health Sciences Centre