An article in today’s New York Times reported on the efficacy of electrical brain stimulation for the treatment of depression. It described a study published last week in the journal JAMA Psychiatry, in which a commonly used antidepressant, sertraline (Zoloft) was compared with transcranial direct current stimulation, or tDCS. This blinded study showed that Zoloft and the electrical stimulation of the brain were equally effective, but the electrical stimulation lacked the side effects of the drug. Combining electrical stimulation with Zoloft produced even better results. This type of electrical stimulation is very safe and is somewhat similar to the transcutaneous electrical stimulation mentioned in my previous post. tDCS was also tried in patients with chronic migraines. A study published in Headache last year showed that pain intensity and migraine duration was reduced after 10 sessions of tDCS given over a period of 4 weeks. Even though the study involved only 13 patients, the active treatment was compared to sham stimulation, which makes the findings more likely to be true, rather than due to the placebo effect. It is too early to recommend tDCS for the treatment of chronic migraines. However, this is a very safe and inexpensive treatment that may be worth trying before other unproven, more expensive, and more invasive treatments, such as occipital or supraorbital nerve stimulation or migraine surgery.

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Electrical stimulation of the nervous system is widely used for a variety of conditions and in a variety of ways. The nervous system can be electrically stimulated at the level of the brain, by implanting electrodes into the brain, at the level of spinal cord, also with implanted electrodes or at the level of peripheral nerves in the skin by attaching an adhesive electrode or with an implanted wires. The conditions that can be helped by electrical stimulation range from Parkinsons disease and depression to chronic low back pain and post-herpetic neuralgia (shingles). Stimulation of the nerves through adhesive electrodes temporarily attached to the skin is called transcutaneous electrical stimulation, or TENS. TENS has been proven to help a variety of musculo-skeletal conditions, such as back pain and arthritis pain.
There have been some studies of the use of TENS for headaches, but none of them have been as rigorous and scientific as the one just published in Neurology. The lead author, a Belgian neurologist and a headache specialist Dr. Jean Schoenen and his colleagues conducted a study on 67 patients with a proprietary TENS device called Cefaly. The device is put on the forehead like eyeglasses and it contains electrodes which stimulate the nerves above the eyes. The study showed that by using this stimulator for 20 minutes daily for 3 months patients reduced the number of their migraine headaches from an average of 7 to 5 a month. Those patients who put on the device but were not given electrical stimulation (the sham, or placebo group) did not improve.
The device costs about $368 on Amazon and $240 at Costco in Canada. It is not clear if this device offers any advantages over a TENS unit that costs about $50 and is widely available in this country. Perhaps, Cefaly is much more convenient in that it does not require adhesive electrodes with wires attached to a little box. Another possible advantage is the stimulating current may have specific frequency, strength and wave shape, which provides better relief. However, an electrical engineer could easily hook up the Cefaly unit to a monitor and figure out and publicize these settings. I do not suggest that the people who developed this device and did all the testing do not deserve to be financially rewarded. They may, in fact be rewarded because their device is significantly more convenient and simple to use and many people will prefer it to a more cumbersome device.
Cefaly
Photo credit: Cefaly.com

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Sudden hearing loss is a rare condition, but it is more common in people who suffer from migraine headaches, according to just published study by Taiwanese researchers. Taiwan, just like many Scandinavian countries has national health insurance and the large computerized data base allows doctors to perform reliable studies of many medical conditions. This study, which was published in Cephalalgia, an international headache journal, involved 10,280 migraine sufferers who were compared to 41,120 healthy control subjects. Doctors examined ten years worth of records of these people and discovered that having migraines almost doubled the risk of sudden hearing loss (the medical term is sudden sensorineural hearing loss). The incidence was about 82 per 100,000 person-years in migraine sufferers and 46 in those without migraines. They also discovered that having hypertension (high blood pressure) increased the risk of sudden hearing loss. This suggests that the hearing loss may be due to sudden drop in blood supply to the hearing nerves. Surprisingly the increased risk was not more pronounced in patients with migraine with aura since vascular problems are more common in those with auras. Treatment of sudden hearing loss requires immediate visit to a doctor, who takes a detailed history, examines the patient, does hearing tests, and obtains an MRI scan of the brain. Sudden loss of hearing can be caused by impacted wax in the ear, brain tumor and other brain disorders, but usually no such causes are found. If no obvious cause is found, treatment typically involves taking a steroid medication. Acupuncture may also help.
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Many migraine sufferers report that flickering lights and vigorous exercise trigger their migraine attacks. Danish researchers published a study in the journal Neurology , in which they recruited 27 patients who suffered from migraines with aura. Of these 27, 12 reported that flickering lights triggered their attacks, 10 reported that vigorous exercise did and 4 felt that both of these were triggers, while only one felt that these were not triggers for her migraine headaches. These patients were then subjected to bright flickering lights for 30-40 minutes, exhausting exercise for 1 hour, or both. None of the 11 patients who were exposed to bright flickering lights developed a migraine, exercise alone triggered a migraine in 4 out of 12 patients (one migraine with aura and three had migraine without aura), while both types of stimulation together triggered a migraine with aura in 2 out of 7. This is a surprising finding, but it does not mean that patients are wrong about flickering light and strenuous exercise triggering migraines. A more likely explanation is that any particular trigger may require certain additional conditions, such as location which is associated with the expected headache, prior conditioning, such as stress that accompanies exposure to bright light in a certain room, added triggers, such as lack of sleep, alcohol, blood caffeine level, and many other. It is also possible that migraine with aura, unlike migraine without aura, is less likely to be triggered by exercise and flickering lights.
If you are exposed to one of your known triggers, if possible, you should try avoiding exposure to other triggers at the same time since it is often a combination of triggers that brings on a migraine. Regular aerobic exercise is one of the most effective preventive treatments for migraine headaches, so patients who are convinced that exercise triggers their headaches can be advised to start slow and gradually increase the duration and the intensity of their exercise. Ideally, everyone should exercise at least three times a week. Stationary bike or an elliptical machine may not be as much of a trigger as running because jarring of the head could also contribute to headaches. If even mild exercise causes a headache, taking an anti-inflammatory medication, such as ibuprofen or Migralex prior to exercise may prevent the headache. After a few weeks the medication may no longer be needed. Whatever is the trigger, general preventive measures will often reduce their impact. Besides exercise, these include getting enough sleep, learning biofeedback or meditation, taking supplements such as magnesium, CoQ10, and other, Botox injections, and as a last resort, prophylactic medications.
running
Photo credit: Run Wild Retreats

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Botox (anabotulinumtoxinA) is the only treatment approved by the FDA for the treatment of chronic migraine headaches. The FDA based its approval on the results of two clinical trials with 700 patients in each (I participated in one of them). In these studies half of the patients were given placebo injections and the other half, Botox for the first six months and then everyone was getting Botox. Even after 4 weeks following the first treatment those who received Botox were doing better than those who received placebo. After the first Botox treatment 49% of participants had a 50% reduction in the number of headache days, after the second treatment this number was 60% and after the thurs, 70%. After 56 weeks, 70% of patients treated with Botox continued to have at least a 50% improvement in headache days per month. This means that by that time 70% of patients were no longer were having chronic migraine, which is defined as having a headache on more than half of the days. So, even in those chronic migraine sufferers who were having daily headaches, a 51% improvement meant that they no longer had headaches on more than half of the days. This also means that Botox converts chronic migraine into episodic. My observation over 18 years of injecting Botox for headaches also indicates that with continued treatment some people stop having migraines altogether. Of course, this observation does not mean that Botox was definitely the reason why headaches stopped since migraines often subside with age and at times can stop without an obvious reason on their own. However, the fact that improvement occurs gradually and continuously with repeated Botox injections suggests that Botox does contribute to this complete resolution of headaches.
Another point I would like to emphasize that some patients who did not a significant improvement after the first treatment did improve after the second or even third. Most of my colleagues and I will not do a third treatment if the first two were completely ineffective. However, if even mild improvement occurs, it may be worth repeating the treatment.
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Migraine surgery continues to be promoted by an ever increasing number of plastic surgeons. In my previous post in 2007 I mentioned the reasons to avoid such surgery and five years later all those reasons remain. Some of the leading objections are lack of proof, existence of a safer alternative (Botox injections), and most importantly, the risk of potentially serious side effects. Several of my colleagues have seen patients who suffered complications of surgery and we decided to ask other patients who underwent migraine surgery to come forward and share their experience. We understand that this will not be a highly scientific study and it will not tell us what percent of people suffer negative outcomes since those who suffered complications and side effects are more likely to come forward than those who had none. However, we think that because doctors who perform surgery are unlikely to report side effects and complications, it is important for people to know what can go wrong. So, please post your experience in response to this blog or if you prefer to remain anonymous, email me at DrMauskop@nyheadache.com.
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Botox relieved severe pain of SUNCT, a rare and very painful condition, according to a report recently published in journal Cephalalgia. SUNCT stands for short-lasting, neuralgiform headache attacks with conjuctival injection and tearing. The pain of SUNCT is very sudden and brief, lasting 5 to 240 seconds and occurring 20-30 or more times a day. The pain usually occurs around the eye and is accompanied by tearing and redness of the eye. It can be a very debilitating condition because it is difficult to treat. Medications, such as lamotrigine (Lamictal), gabapentin (Neurontin), carbamazepine (Tegretol), and other have been reported to help. The report in Cephalalgia by a Spanish neurologist describes a patient with SUNCT who did not respond to a variety of medication and nerve destruction (thermocoagulation of the trigeminal ganglion), but had an excellent response to Botox injections given every three months. He has received 10 Botox injections over a period of 2 and 1/2 years with sustained relief. He was still having 6-8 attacks per week, but before Botox he was having 20-30 a day. His functioning has also significantly improved. Botox is approved by the FDA only for chronic migraines, although it also seems to work for cluster headaches, which cause pain similar to SUNCT, although it lasts for 1-3 hours and occurs once or twice a day. SUNCT is a very rare condition and it is very unlikely that a blinded clinical trial of Botox for SUNCT will ever be conducted, but this report suggests that Botox may be worth trying in patients with SUNCT.
SUNCT

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Zecuity was just approved by the FDA for the treatment of acute migraines. Zecuity is a skin patch containing sumatriptan. Delivering sumatriptan through the skin is an appealing option for patients who have severe nausea or vomiting and have difficulty swallowing tablets. NuPath is a company that has been working on such a delivery system for several years and I mentioned their research in one of the posts on this blog over three years ago. Recently, they completed another clinical trial which confirmed that the idea is valid and their product (it was first named Zelrix, but now is to be called Zecuity) is effective in treating migraine attacks. The patch containing sumatriptan delivers medicine through the skin with the help of an electrical current derived from a miniature battery embedded within the patch. The patch is used once and then is discarded. The results of this trial were published in the journal Headache. This study involved 469 patients half of whom treated their migraine with an active patch and the other half with an inactive (placebo) patch. A significantly higher proportion of patients given sumatriptan were completely pain-free compared to those who were given placebo – 18% vs 9%. Pain relief after two hours was observed in 53% patients receiving sumatriptan compared to 29% of those receiving placebo and this difference persisted. Side effects were mostly local due to the patch – 23% had pain at the site of patch, 20% had either burning of tingling, and 7% had other types of skin reaction, but only 2% had a reaction severe enough that they took the patch off. Zecuity (transdermal sumatriptan) appears to offer a good option for migraine sufferers who cannot take oral medications and do not want to inject themselves with sumatriptan.
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Newer oral contraceptives increase the risk of strokes and other types of blood clots in patients with migraines with aura, according to a study to be presented at the next meeting of the American Academy of Neurology in San Diego in March. We have known for many years that estrogen-based oral contraceptives increase the risk of strokes in women who suffer from migraines with aura. However, most of the studies were done looking at the old contraceptives which contain a relatively high amount of estrogen (such as Ortho-Novum 1/50, Ovral, Ogestrel, and other). It was logical to assume that the newer contraceptives (such as Yaz, Yasmin, Loestrin, and other) with lower amounts of estrogen would be safer. Most headache specialists, myself included, were not as adamant about avoiding the newer low-dose estrogen contraceptives in our patients who had migraine auras. I would always discuss the risk of strokes and other blood clots with my patients and would always suggest using other modes of contraception, but if other methods were not acceptable to the woman or if the contraceptive had other benefits (helped PMS, acne, regulated periods, reduced bleeding, etc) I would not make a big fuss. This new study will make me more insistent on stopping the pill because the risk appears to be even higher with the newer contraceptives than with the old ones. Even the vaginal ring (NuvaRing), which I mentioned in a recent post as a good option to reduce menstrual migraines, carries a higher risk than the old oral contraceptives. The ring has a low dose of estrogen, but it is speculated that the risk is further increased because estrogen is released continuously (with the pill estrogen goes in and out of the body daily). The same may apply to estrogen patches, such as Ortho Evra. The study looked at over 145 thousand women, which makes its conclusions fairly reliable. Another surprising finding of this study is that the risk of blood clots in legs (deep vein thrombosis) was very high – 7.6% in women with migraine with aura and 6.3% in those without aura taking contraceptives.
The bottom line, if you suffer from migraines with aura do not take estrogen-based contraceptives, whether in a pill, patch, or ring, unless you and your doctor decide that the benefits outweigh the risks.
Yaz
Ortho Evra

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Some features of migraine with aura clearly set it apart from migraines without aura. Aura is present in 15% to 20% of migraine sufferers. Most often it is a visual disturbance, which consists of either gradual loss of vision, starting from the periphery of visual field and moving to the midline. Many people see shimmering and sparkling lights with or without loss of vision and some see things smaller than they are. Sensory aura consists of pins-and-needles, tingling and numbness on one side of the body, often starting with the hand, moving up the arm and then involving the face. Typical aura lasts 20-60 minutes, but it can be shorter or longer. Auras are usually followed by a headache, but sometimes it occurs without any pain. People who have auras are at a slightly higher risk of having a stroke. This risk is magnified by other factors, such as smoking, high-dose estrogen contraceptives, hypertension, diabetes, and high cholesterol.
A recent study by Austrian neurologists published in Headache examined 54 patients who kept a detailed diary and recorded a total of 354 migraine auras. Using a statistical tool called multivariate analysis they discovered that smoking, menstruation, and hunger were likely to increase the risk of having an aura. Holidays and days off reduced the possibility of experiencing an aura. They also found that non-migraine headaches and migraine without aura were more likely to occur during menstruation, psychological stress, tiredness, odors, and were decreased by smoking.
The surprising finding in this study is that the risk of having a migraine with aura was doubled in the first three days of menstruation. The consensus of headache specialists has been that menstrual migraine is typically a migraine without aura, although at least one other study by Danish doctors also reported menstruation as a trigger of migraine with aura.

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Transcranial magnetic stimulation (TMS) seems to be effective for the treatment of migraines with aura. “Spring TMS” device which delivers a jolt of such stimulation has been on the market in Europe since 2011. The American company that manufactures this device, eNeura Therapeutics hopes to obtain approval to sell it in the US in the near future. The approval of this device in Europe was based on a multi-center study results of which were published in Lancet Neurology. Unfortunately, the device is fairly bulky and needs to be carried around constantly because it seems to work only if used during the aura phase of the migraine. Auras usually begin unpredictably and last 20-60 minutes. Migraine with aura affects only 15-20% of all migraine sufferers, further limiting the potential market for this device.

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Migraine headaches that occur at around the time of menstrual period tend to be more severe and more difficult to treat. Analysis of studies that involved 187 women with menstrual migraines who treated at least one of their attacks with frovatriptan (Frova) and one with another triptan showed that frovatriptan was more effective. While all triptans were equally effective in providing pain relief at 2 and 4 hours, rate of headache recurrence was significantly lower for frovatriptan. After 24 hours, 11% of women who took frovatriptan had a recurrence of their headache, but with other triptans 24% had their migraine come back. After 48 hours, the numbers were 15% for frovatriptan and 26% for other triptans. One caveat is that all of these studies were funded by the maker of frovatriptan.

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