Migraine and headache treatments is undoubtedly the most discussed topic among patients. Yes, we also want to know more about the _ pathophysiology_ of Migraine, cluster headache, and other headache disorders; but most of us have to work with our treatments on a daily basis.
For quite some time, that meant that the most discussed topic was medications. Today, more of the discussion centers on the different types of neurostimulators that are being used for headache and Migraine treatment. Two recent events are adding fuel to the neurostimulator discussion:
- The December, 2013, FDA approval of the Cerena transcranial magnetic stimulation (TMS) device.
- The March, 2014, FDA approval of the Cefaly transcutaneous electrical nerve stimulation (TENS) device. (Important note: The Cefaly is the ONLY TENS unit that is safe to use above the neck.)
Electrical and magnetic stimulators for Migraine and headache have been an area of research for some time now, and that research continues. There are currently five types of stimulators being used or researched for Migraine and headache:
- Vagal Nerve Stimulation (VNS) (see image above for example): VNS is being investigated for both Migraine and cluster headaches - both for prevention and for treating attacks when they occur. Currently, work is progressing with a hand-held device that was developed to make VNS more convenient and less dangerous than an implanted unit would be. This is called noninvasive vagal nerve stimulation (nVNS). This device is approved for use in Europe and Canada, but it’s not yet FDA approved for use in the U.S. At this time, there are four trials of this device in progress.
- Transcranial Magnetic Stimulation (TMS) (see image above for example): TMS has been investigated for both Migraine prevention and use when a migraine occurs. The non-invasive device delivers a magnetic charge at the back of the head. Preventively, studies showed a decrease in both frequency and severity of Migraine attacks in both Migraine with aura and Migraine without aura. For use when a Migraine occurs, benefit has been found for Migraine with aura only at this time. In December, 2013, the FDA approved the Cerena TMS device from eNeura. This device, however, is their first generation device and will not be released. Their Spring TMS device will be released when approved by the FDA. For more on this, see _Transcranial Magnetic Stimulation for Migraine a Step Closer _.
- Sphenopalatine Ganglion (SPG) Stimulation (see image above for example): SPG stimulators are being tested to treat Migraine and cluster headache. This tiny stimulator is implanted through the roof of the mouth to rest just behind the cheek. Although it’s implanted, there are no wired or batteries. The SPG stimulator is controlled with a small remote controller to deliver an electrical current. A European study of the device shown above, made by Autonomic Technologies, resulted in 55% of cluster patients reporting pain relief within 15 minutes and 42% being able to prevent cluster attacks. The device is approved in Europe for chronic cluster headaches and a major study with cluster patients is planned in the U.S. It’s safe for patients with an SPG stimulator in place to have an MRI.
- Occipital Nerve Stimulation (ONS or ONSTIM) (see image above for example): This is the type of stimulator that was most discussed for some time. Despite the fact that no ONSTIM device has been approved by the FDA, there are some doctors and centers that implant these devices. ONSTIM works by stimulating the occipital nerves at the back of the head. Three ONSTIM trials have been completed, but their results were not significantly positive. The device is approved in Europe, and there are plans for one more study for use in Chronic Migraine in both Europe and the U.S. Patients cannot have an MRI with an ONS device implanted because of the metal in the device.
- Hypothalamic Deep Brain Stimulation (DBS): DBS involves implanting a stimulator deep in the brain’s hypothalamus, which makes the procedure for implant quite risky and invasive. There is a risk of brain bleeding and death. There have been no placebo-controlled studies of DBS. A small number of cluster headache cases have had promising results.
Summary and Comments:This is a very promising area of research for potential Migraine and headache treatments. The FDA approval of the Cefaly marks the first stimulator to be approved and brought to market. See _Cefaly Device Approved by the FDA for Migraine Treatment _ for more information.
When considering treatment with a stimulator, especially those that are implanted, patients need to weigh the risks against the benefits. One particular drawback of ONSTIM is that patients with an ONS device implanted cannot have an MRI because of the metal in the devices.
At this time, none of the implantable stimulators are approved by the FDA. For that reason, many insurance companies don’t cover them. If you speak with a doctor or a staff member who tells you they can get it covered by insurance, specifically ask them what diagnosis they submit with the claim to get it covered. Some are getting it covered by submitting the claim with diagnoses other than Migraine or headache - occipital neuralgia, for example. If insurance claims are filed with a diagnosis of a condition, you don’t have, that constitutes insurance fraud. If discovered, that can have serious repercussions for you and the doctor.
Waiting for treatment advances to be approved by the FDA can seem torturous. I’ve been waiting for the Spring TMS device to be approved for several years now. The approval of the Cerena device makes me hopeful that the Spring device will be approved soon. In the meantime, I should receive a Cefaly device the first part of April and am anxious to see if it works for me.
As more news of trials and / or FDA approval of stimulation devices becomes available, I’ll be sure to keep you updated.
Tepper, Deborah, MD. “Stimulators for the Treatment of Headache.” American Headache Society Headache Toolbox. Headache 2014;54:593-594.
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© Teri Robert, 2014 Last updated March 24, 2014.
Author of “Living Well with Migraine Disease and Headaches”