The FDA has cleared a noninvasive vagal nerve stimulation (VNS) device to treat episodic cluster headache, .
The company's gammaCore VNS device, which doesn't require implantation, sends a mild electrical signal to the vagal nerve through the skin to block the pain of episodic cluster headache.
"This is the first vagal nerve stimulator for cluster headache," Richard Lipton, MD, of Montefiore Medical Center in Bronx, N.Y., told 鶹ý, adding that many other VNS systems are implanted surgically. "This is a safe, simple, portable device."
It's only approved, however, for episodic cluster headache, not chronic cluster headache, as the device failed to show benefit for this group in a clinical trial.
The ACT1 and ACT2 trials (Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache) did show benefits for patients with episodic cluster headache.
In ACT1, which included 85 patients with episodic cluster headache, more patients had a reduction in pain with the nerve stimulator compared with placebo (34.2% versus 10.6%, P=0.008). In ACT2, which included 27 patients with episodic cluster headache, more patients using the VNS system experienced pain reduction compared with placebo (47.5% versus 6.2%, P=0.003).