What side effects are associated with this type of intervention?

Common treatments for Panic Disorder that involve neuromodulation, such as Trigeminal Nerve Stimulation (TNS), Transcranial Magnetic Stimulation (TMS), and Vagus Nerve Stimulation (VNS), generally have mild side effects. These can include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Panic Disorder, including selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and benzodiazepines like alprazolam and clonazepam. While Trigeminal Nerve Stimulation (TNS) is an emerging neuromodulation technique being studied for its efficacy in treating anxiety disorders, including Panic Disorder, it has not yet received FDA approval specifically for this indication. Current FDA-approved treatments primarily involve pharmacotherapy rather than neuromodulation techniques.

What other types of research exist?

Promising novel alternatives to Trigeminal Nerve Stimulation for treating Panic Disorder in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive symptoms and may benefit anxiety disorders; 2) Transcranial Direct Current Stimulation (tDCS), which has demonstrated potential in enhancing neurocognition and reducing depressive relapses; and 3) Cranial Electrotherapy Stimulation (CES), which has been piloted for safety and efficacy in treating depression and may be applicable to anxiety disorders. These alternatives offer non-invasive options with varying mechanisms of action that could be considered in consultation with a healthcare provider.

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Neurostimulation

Trigeminal Nerve Stimulation for Anxiety Disorders

N/A

Waitlist Available

Led By Rafael Freire, MD PhD

Research Sponsored by Dr. Rafael Freire

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up clinical global impression - severity scale (cgi-s) will be administered two weeks after the end of the treatment.

Summary

This trial is testing a treatment called trigeminal nerve stimulation, which involves sending electrical signals to a nerve in the face. It aims to help patients with panic disorder, generalized anxiety disorder, and social anxiety disorder. The treatment works by calming brain activity to reduce anxiety symptoms. Trigeminal nerve stimulation (TNS) is a promising strategy in treating diseases of the nervous system, including epilepsy and traumatic brain injury.

Who is the study for?

This trial is for individuals who have been diagnosed with panic disorder, social anxiety disorder, or generalized anxiety disorder according to DSM5 criteria. It's not specified who can't join the trial.

What is being tested?

The study is testing trigeminal nerve stimulation (TNS) as a treatment for various anxiety disorders. Participants will receive either active TNS or a sham (placebo) version to compare effectiveness and tolerability.

What are the potential side effects?

While specific side effects are not listed, TNS is generally considered low-risk. Potential side effects might include discomfort at the stimulation site or mild headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ clinical global impression - improvement scale (cgi-i) will be administered two weeks after the end of the treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~clinical global impression - improvement scale (cgi-i) will be administered two weeks after the end of the treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical global impression - improvement scale (cgi-i) will be administered two weeks after the end of the treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Remission

Response

Secondary study objectives

Functioning

Generalized anxiety disorder symptoms

Panic disorder symptoms

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

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.

Group II: Sham stimulationPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Panic Disorder include selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, and cognitive-behavioral therapy (CBT). SSRIs work by increasing serotonin levels in the brain, which helps regulate mood and anxiety. Benzodiazepines enhance the effect of the neurotransmitter GABA, providing quick relief from acute anxiety symptoms. CBT focuses on changing negative thought patterns and behaviors associated with panic attacks. Trigeminal Nerve Stimulation (TNS) is being studied as a treatment that modulates neural activity in the trigeminal nerve to alleviate anxiety symptoms. This is significant for Panic Disorder patients as it offers a potential non-pharmacologic option that directly targets neural pathways involved in anxiety, potentially reducing side effects associated with medications.