Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Dr. Rafael Freire

Status: Active, not recruiting

Conditions: Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Treatments: Device: Trigeminal nerve stimulation - sham; Device: Trigeminal nerve stimulation - active

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04931134

6028648

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups

Active stimulation

Experimental group

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.

Treatment:

Device: Trigeminal nerve stimulation - active

Sham stimulation

Sham Comparator group

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.

Treatment:

Device: Trigeminal nerve stimulation - sham