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What is GammaCore™ nVNS for headaches, and investigational for PTSD and Anxiety?

The gammaCore™ non-invasive vagus nerve stimulation (nVNS) is a portable, easy-to-use, hand-held medical device used to treat various conditions, including anxiety and PTSD (post-traumatic stress disorder). The device works by delivering mild electrical stimulation to the vagus nerve, which is a key part of the autonomic nervous system involved in regulating various bodily functions, including mood and stress response.

Indications

The gammaCore™ nVNS is typically recommended to treat anxiety and PTSD when other conservative treatment strategies such as medications or injections have not been effective or when individuals do not wish to take medications or injections due to undesirable side effects.

In anxiety and PTSD, there is often dysregulation of the stress response system. This can manifest as hyperarousal, increased anxiety, avoidance behaviors, and intrusive thoughts. Vagus nerve stimulation with gammaCore™ nVNS is thought to help modulate this dysregulation, leading to a more balanced stress response.

What Does gammaCore™ nVNS Therapy for Anxiety and PTSD Involve?

The vagus nerve is a major nerve that runs from the brainstem through the neck and into the chest and abdomen. The gammaCore™ nVNS involves placing a handheld device against the skin of the neck. The device delivers mild electrical impulses to the vagus nerve through the skin, without the need for surgery or implantation. The electrical stimulation from gammaCore™ nVNS modulates the activity of the vagus nerve, affecting the balance of the autonomic nervous system. This can lead to changes in heart rate, blood pressure, and neurotransmitter levels, which are believed to contribute to its therapeutic effects. The specific therapeutic effects of gammaCore™ nVNS can vary depending on the condition being treated. For example, in the case of anxiety and PTSD, the device may help regulate the body's stress response, reduce anxiety symptoms, and improve overall well-being.

Procedure for gammaCore™ nVNS Therapy for Anxiety and PTSD

In general, the procedure for gammaCore™ nVNS for anxiety and PTSD may involve the following steps:

  • The healthcare provider or a trained professional will demonstrate how to use the gammaCore™ device.
  • The device typically consists of a handheld unit with electrodes that are placed on the skin over the vagus nerve in the neck.
  • Before starting the therapy, ensure that the skin where the electrodes will be placed is clean and dry.
  • If necessary, shave any hair from the area to ensure good contact with the skin.
  • Sit or lie down comfortably in a relaxed position.
  • Hold the gammaCore™ device against the neck, specifically on the side where the vagus nerve is located.
  • Turn on the gammaCore™ device and follow the instructions provided by the healthcare provider.
  • The device will deliver mild electrical stimulation to the vagus nerve through the skin.
  • The frequency, duration, and intensity of stimulation may vary based on the condition being treated and the individual's response to treatment.

Risks and Side Effects

The common side effects associated with gammaCore™ nVNS therapy for anxiety and PTSD include:

  • Application site redness/irritation
  • Application site discomfort
  • Dizziness
  • Headaches/migraines
  • Local pain, including face, head, and neck area
  • Muscle twitching and/or contractions
  • Pricking, tingling, or a feeling of “pins and needles” on the skin where the device is applied

These side effects usually resolve immediately after the stimulation is complete.

Summary

Overall, gammaCore™ nVNS therapy is designed to be user-friendly and can be administered both in a clinical setting and at home under appropriate guidance and supervision. Depending on the treatment plan, patients may be trained to use the gammaCore™ device at home. Patients will be instructed on proper device maintenance, electrode placement, and safety precautions for home use. Regular follow-up appointments with the healthcare provider are important to assess the effectiveness of gammaCore™ nVNS therapy and make any necessary adjustments to the treatment plan.

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For informational purposes only, a link to the federal Centers for Medicare and Medicaid Services (CMS) Open Payments web page is provided here. The federal Physician Payments Sunshine Act requires that detailed information about payment and other payments of value worth over ten dollars ($10) from manufacturers of drugs, medical devices, and biologics to physicians and teaching hospitals be made available to the public.

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