An electric stimulation device, gammaCore has received clearance from the U.S. Food and Drug Administration (FDA) as an acute treatment of pain associated with migraine in adult patients. gammaCore is a hand-held device that stimulates the vagus nerve in the neck through the skin and was developed following and based on my 2005 publication describing the use of implantable vagus nerve stimulator for refractory chronic cluster and migraine headaches. This adds to the approval gammaCore received for the acute treatment of pain associated with episodic cluster headache in adult patients in April 2017. The clearance is limited to pain of migraine, rather than migraine attacks, meaning that the device relieves pain and may not relieve other migraine symptoms, such as nausea and sensitivity to light and noise.
The FDA clearance of gammaCore for the acute treatment of pain associated with migraine was supported by the results of the multicenter, randomized, double-blind, sham-controlled trial that demonstrated that “treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with sham treatment”. Just like with all other studies with gammaCore, the therapy was found to be well tolerated by patients.
gammaCore is also available outside of the U.S., including in Canada and the European Economic Area. The manufacturer offers a free trial of the device, which cannot be purchased, but only rented. Some insurance plans may pay for the rental.
Here are a few disclaimers and warnings from the manufacturer:
The safety and effectiveness of gammaCore (non-invasive vagus nerve stimulator) has not been established in the acute treatment of chronic Cluster Headache.
This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
The long-term effects of the chronic use of the device have not been evaluated.
Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for:
Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
Pediatric patients
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Patients should not use gammaCore if they:
Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
Are using another device at the same time (eg, TENS Unit, muscle stimulator) or any portable electronic device (eg, mobile phone)
