Trial Testing Non-Invasive Neurostimulation for Migraine

A clinical trial is underway testing a hand-held device developed by Electrocore LLC in Basking Ridge, New Jersey that stimulates the vagus nerve as a treatment for migraine and cluster headaches. The company says it completed enrollment of 60 patients at six sites in the U.S., with results of the study expected in the second quarter of 2014.

The Electrocore device, called gammaCore, sends electrical signals from outside the body to stimulate the vagus nerves, which run on each side of the body from the brainstem to the chest and abdomen. Impulses sent along the nerve to the brainstem, which then sends signals to areas of the brain. Vagus nerve stimulation is used in various forms to treat symptoms of epilepsy and depression, but usually require implanted devices or electrodes.

Patients place the gammaCore device against the vagus nerve at the spot on the neck where the cartoid pulse is located. Signals from the device, says Electrocore, stimulate the afferent fibers in the vagus nerve that extend to the brainstem. There, the signals stimulate release of inhibitory neurotransmitters in the brain that the company says may reduce glutamates that excite nerve cells in the brain.

The clinical trial involves patients who experience migraine headaches more than 15 days a month. After a one-month period to collect baseline data, participants will be randomly given either a gammaCore or fake stimulator device.

The patients will then use the assigned device for two months, and record the number of days they have headaches and their severity. Following the two-month test period, all participants will use the gammaCore for another six months.

The trial is also testing the device for safety, recording serious adverse effects of patients using the gammaCore or fake device during the test phase of the study.

Read more:

• FDA Approves Acute Migraine Treatment Patch System
• European Approval Granted for Implanted Migraine Device
• Trial to Test Gel-Coated Coils for Treating Aneurysms
• Patent Awarded for Migraine Drug Inhalation Method
• FDA Approves Portable Device to Spot Brain Bleeding

Photo: Sasha Wolff/Flickr

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