TENS Tiara to Be Marketed for Migraine Prevention

Apr 02, 2014, by Dr. Becky Coats

The FDA has looked over data in support of Cefaly, a small, portable battery-powered device for migraine prevention, and it has decided the device can be marketed in the US for that indication.

New Migraine TENS TiaraWhat Is Cefaly?

Cefaly is a form of TENS (transcutaneous electrical nerve stimulation) that sits on the forehead with arms that go over the ears. It has a sleek and futuristic design that might look at home on the brow of Queen Amidala.

It uses a very mild electric current that is intended to go through the skin and stimulate branches of the trigeminal nerve, which is one of the places where migraines are triggered. It doesn’t stimulate muscle contractions like the TENS we use in our office. It is intended to be used for about 20 minutes a day by patients age 18 or older. The device uses disposable electrodes that can be used several times before being worn out.

Modest Results

Since Cefaly is considered a low-risk device, the FDA decided that it could be marketed after looking at just two studies. In one of the studies, 67 individuals used either Cefaly or a placebo device. People who used Cefaly had significantly fewer headaches than those who used the placebo device. Cefaly also allowed people to use less pain medication. However, when headaches occurred, they were just as severe for users of the placebo device and users of Cefaly.

In the other study, more than 2300 people who use the device in France and Belgium (where the device has been in use since at least 2011) were surveyed about the device. About 53% of users were satisfied with the device and were willing to buy it for continued use. Only 4% of users experienced side effects, all of which were minor and reversible. On its website, the manufacturer promotes better numbers than the FDA reported.

More Effective Migraine Treatment

Trigeminal nerve stimulation can help reduce the incidence of migraines, but migraines can also be triggered by muscle tension. In people with TMJ, an imbalanced jaw can irritate the trigeminal nerve, leading to a migraine. Conventional tension headaches caused by poor working of the temporomandibular joint can also trigger migraines.

TMJ treatment has been shown to reduce not just the frequency of migraines, but also their severity.

To learn whether TMJ might be playing a role in your migraines, please call 817-481-6888 for an appointment at Grapevine Dental Care in Grapevine, Texas today.