A handheld vagus nerve stimulation device used for the treatment of episodic cluster headaches has been approved by the Food and Drug Administration (FDA) on April 18.
Also known as "suicide headaches," these headaches are extremely severe and affect fewer than 1 percent of people — mostly men. The illness comes and goes in clusters and episodes, with patients not experiencing pain for months and then suffering several sudden headaches in a single day or more.
Prior to the FDA approval, there has not been any specific treatment for cluster headaches, but patients do take migraine drug sumatriptan, which is delivered through auto-injector, as well as inhaled oxygen. These methods are limited and often inconvenient.
Now, the FDA approved the use of handheld device called GammaCore, which was developed by a New Jersey-based company known as ElectroCore, in the United States.
This special device has long been available in Europe and treats pain by sending mild electrical stimulation to the vagus nerve. The device is applied to the neck during a headache.
Effectiveness Of Vagus Nerve Stimulation Therapy
Data shows that more than 350,000 people in the United States suffer from cluster headaches. The FDA release was based on two trials: the placebo-controlled ACT1 and ACT2 trials.
The first trial involved 85 patients with episodic cluster headaches. In the study, 34 percent of the respondents who used the device reported pain reduction compared to 10.6 percent of the placebo group.
The second trial included 27 patients with 182 total pain attacks. The findings showed that 47.5 percent of those treated with GammaCore were pain-free after 15 minutes, while only 6.2 percent of those who used the placebo were pain-free.
In 2016, a study found that vagus nerve stimulation therapy is effective in easing pain among rheumatoid arthritis patients.
Mild Side Effects
Researchers said treatment using the vagus nerve stimulation device displayed mild and transient side effects.
Dr. Stephen Silberstein, director of the Headache Center at Jefferson University, said GammaCore does not have dose limitations or side effects commonly found in prescribed treatments. There is no need for invasive surgical procedures, which can be high-risk, inconvenient, and costly.
Silberstein also said the approval is a milestone for the treatment of cluster headaches.
"It is a way for patients to treat their symptoms as often as they need to use the device," he added.
Meanwhile, ElectroCore warned that the vagus nerve stimulation device should not be used by patients with active implantable medical device, such as hearing aid implant or pacemaker; patients with hypotension, hypertension, tachycardia, or bradycardia; as well as children or pregnant women.