The gammaCore non-invasive vagus nerve stimulator from electroCore, a Basking Ridge, New Jersey company, is now available for adult patients to treat acute pain arising from episodic cluster headaches. Currently only available with a doctor’s prescription, the gammaCore device is used to transmit an electric current through the neck and to the vagus nerve. This is done by placing the electrodes of the gammaCore on the side of the neck and initiating the device’s therapy routine.\r\n\r\nThe gammaCore can be used just about anywhere and it’s small enough to be taken along to work or on trips. There is no maximum frequency of use that’s indicated, so patients can apply it to fight the headaches’ pain as often as they’d like. In the long run, it is hoped that the device will result in fewer patients relying on drugs to alleviate pain, reducing the chances for side effects and hopefully leading to improved results.\r\n\r\nHere’s some info, according to electroCore, about what led to the FDA regulatory clearance earlier this year:\r\n\r\nThe FDA release of gammaCore is based on subgroup analyses from two trials in the ACT (Non–Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache) clinical trial program evaluating the safety and efficacy of gammaCore for the acute treatment of episodic cluster headache. Both trials (ACT1 and ACT2) were prospective, double-blind, placebo-controlled, randomized studies evaluating the use of gammaCore versus placebo. Results from ACT1, evaluating 85 patients with episodic cluster headache, found that 34.2% of patients experienced a reduction in pain from episodic cluster headache (defined as the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore for the first treated cluster headache attack in the study; use of rescue medication within 60 minutes was considered a treatment failure) compared to 10.6% in patients treated with placebo (p=0.008).Results from ACT2, evaluating 182 attacks in 27 patients with episodic cluster headache, also found that a significantly higher percentage of attacks were pain-free (defined as pain-free at 15 minutes after the onset of pain from cluster headache with no use of rescue medication through the 30-minute treatment period) in patients treated with gammaCore (47.5%) versus placebo (6.2%; p=0.003). In both trials, gammaCore was found to be safe and well-tolerated, with the majority of adverse events (AEs) being mild and transient and occurring during the time of active treatment.