Cerena Transcranial Magnetic Stimulator (TMS) for Migraine: New Non-Drug Treatment Approved by FDA
The Cerena Transcranial Magnetic Stimulator was approved by the FDA on December 13 2013 for treatment of acute migraine with aura. The TMS system for treating migraine is unique in that it involves no medication, but instead uses magnetic stimulators placed by the patient on the back of the head, on the scalp. TMS seems to work by altering the electrical signals in part of the brain that is overactive during a migraine headache.
Migraine headaches are a major source of disability worldwide. They can affect one or both sides of the head, usually resulting in a throbbing or pounding pain worsened by light and noise. Often migraines also are accompanied by nausea or vomiting, which can make taking medication difficult. Migraine aura is typically a visual disturbance experienced just prior to the headache. Standard migraine treatments are not always effective for migraine symptoms, and for some patients who have frequent migraines, taking medication can cause more pain, a chronic headache syndrome called medication overuse headache. Standard treatments are also not options for certain patients such as pregnant women, people who take certain types of antidepressants, and people with certain vascular conditions.
How well does it work?
The Cerena system certainly adds an attractive option for treating migraine. However, there is only one small clinical trial, sponsored by a manufacturer of a similar system in the United Kingdom, treating 113 patients demonstrating an effectiveness of 39% in 2 hours. In this trial, 4 patients would need to be treated for 1 to be relieved of their pain 24 hours later. In contrast, injectable sumatriptan has an effectiveness of 80%. The European Headache Federation cautions that ” no firm conclusion can be drawn by these studies”.
Is it safe?
The trial itself did not demonstrate major side effects to TMS, however, it was very small. A review done of thousands of cases of uses of TMS suggests that there are very few major side effects. A single study of repetitive TMS for migraine prevention suggested that the technique may be safe in pregnant women, however more studies will need to be done before safety in pregnancy is clear. A question that is still open is whether single pulse TMS used in frequent migraines will lead to more or less migraines in the long run. Also, while one study suggested that TMS retains its effectiveness and safety when the patient is taking migraine preventive medication, more studies on use of TMS with preventives would be reassuring.
In summary, the Cerena system is a new, drug free way of treating migraines. It is not as effective as some drug treatments, but may offer an advantage to patients who cannot take first line medications, or for whom medication does not work. More research needs to be done as to whether the system is safe for repetitive use over the long term, and what the long term risks are.
Lipton, Richard B., David W. Dodick, Stephen D. Silberstein, Joel R. Saper, Sheena K. Aurora, Starr H. Pearlman, Robert E. Fischell, Patricia L. Ruppel, and Peter J. Goadsby. “Single-pulse Transcranial Magnetic Stimulation for Acute Treatment of Migraine with Aura: A Randomised, Double-blind, Parallel-group, Sham-controlled Trial.” The Lancet Neurology 9.4 (2010): 373-80. Print.
Martelletti, Paolo, Rigmor H. Jensen, Andrea Antal, Roberto Arcioni, Filippo Brighina, Marina De Tommaso, Angelo Frazini, Denys Fontayne, Max Heiland, Tim P. Jurgens, Massimo Leone, Delphine Magiss, Koen Paemeleire, Stephano Palmisani, Walter Paulus, and Arne May. “Neuromodulation of Chronic Headaches: Position Statement from the European Headache Federation.” The Journal of Headache and Pain 14.1 (2013): 86. Print.