- How does the device work?
Recent animal data suggest that the mechanism of action may involve inhibition of glutamate production in the trigeminal nucleus caudalis.
- Is VNS with the gammaCore therapy safe?
The chronic use of implantable VNS devices at therapeutic levels have not been shown to cause clinically meaningful decreases in heart rate, blood pressure or increases in airway resistance. Chronic stimulation with implanted vagus nerve stimulation devices and electroCore’s pre-clinical and clinical experience have demonstrated that certain electrical output characteristics, that are sufficient to provide therapeutic benefit for a variety of conditions, do not result in increased efferent neural activity that is associated with bradycardia, bronchoconstriction. Moreover, stimulation itself does not produce serious or permanent damage to the nerve or any other adverse reactions. The gammaCore device is not implantable, is not in direct physical contact with the vagus nerve, and provides stimulation for a maximum of only 120 seconds per use (the 90-second dose, with an additional 30-seconds provided to ensure placement and amplitude setting of the device). Further, the patient controls the gammaCore stimulation intensity.
- What are the possible side effects?
There have been no reported serious side effects of nVNS stimulation. Mild muscle twitching, or pain (due to over stimulation), transient hoarseness or voice changes, and mild skin irritation have been reported, but all have resolved by the conclusion of the treatment or shortly thereafter. According to the literature related to implantable VNS, and other electrical stimulation technologies, cough, paresthesia, dysaesthesia, or syncope could theoretically occur during treatment, but have not been observed with nVNS.