Cluster headaches

Two landmark studies on an entirely new type of treatment for migraines have been just published in the New England Journal of Medicine.

One of the reports describes a phase 3 trial (final phase that can lead to the FDA approval), which was conducted by Teva Pharmaceuticals using a monoclonal antibody, fremanezumab to treat patients with chronic migraine (patients with 15 or more headache days each month). The study involved 1,130 patients who were divided into three groups: one group received monthly injections (subcutaneously, i.e. under the skin) of the active medicine, another group was given an injection of the real medicine every 3 months and placebo injections monthly in between, and the third group received placebo injections every month. Patients in both groups that received real shots did much better than those given placebo. They had fewer days with headaches, used less of the abortive migraine medications, and had a lower impact of migraines on their lives. The effect of the drug lasted 3 months, which suggests that one injection every three months will be sufficient. We also hope that patients will be able to inject themselves and not have to come to doctors’ offices every month. The side effects were mostly related to the injection itself – pain, swelling, and bruising.

The second study conducted by Amgen and Novartis utilized a similar drug, erenumab (it will have the brand name of Aimovig when it becomes available in the middle of next year) to prevent episodic migraines, that is migraines that occur on fewer than 15 headache days each month. A total of 955 patients participated in this study and they were also divided into three groups: those receiving either 70 or 140 mg of medicine and a group receiving placebo. Injections were given monthly to prevent migraine attacks. Both doses of the drug resulted in significantly fewer migraine attacks and improvement in physical impairment and everyday activities. Side effects were mostly due to the injection site reactions, just like with fremanezumab.

Both fremanezumab and erenumab belong to the family of CGRP monoclonal antibodies, drugs that block a neurotransmitter CGRP which is released during a migraine attack. Two additional companies, Eli Lilly and Alder are developing similar drugs, galcanezumab and eptinezumab, which are also expected to be approved next year. Eli Lilly’s drug is also being tested for the prevention of episodic cluster headaches.

I first wrote about the CGRP drugs in a blog post in 2007, more than 10 years ago. At that point CGRP was the target of research for over 10 years, so in total, it will have taken 20 years to bring these new drugs to the market. It was even longer with triptans, such as sumatriptan (Imitrex) – it took 30 years since the discovery of the potential role of serotonin to the approval of sumatriptan. The drug development process takes not only decades of time, but also billions of dollars, which explains why new drugs are so expensive, at least in the first few years. After years of being on the market, prices of drugs tend to go down and now 90 tablets of sumatriptan can be bought for $70 at Costco, while similar branded triptan drugs used to cost $40 for a single tablet.

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Botox is the most effective and the safest preventive treatment for migraine headaches. However, in a very small number of patients, Botox loses its effectiveness over time. This happens for two main reasons – the person develops antibodies as a defense mechanism to block the effect of Botox or headaches change in character and stop responding to Botox.

It is easy to tell these two reasons apart. If Botox fails to stop movement of the forehead muscles and the patient can frown and raise her eyebrows, it is most likely because of antibodies. On a very rare occasion this is due to a defective vial of Botox, so to confirm that antibodies have formed, we give a small test dose amount of Botox into the forehead. If again there is no paralysis, we know that antibodies have developed. This can happen after one or two treatments or after 10, but in my experience over the past 25 years, significantly fewer than 1% of patients develop this problem.

Fortunately, some patients who develop antibodies to Botox, known as type A toxin, may respond to a similar product Myobloc, which is a type B toxin. Myobloc is not approved by the FDA to treat chronic migraine headaches, but it has a similar mechanism of action and has been shown to relieve migraines in several studies. Injections of Myobloc can be a little more painful, it begins to work a little faster than Botox, but the effect may last for a slightly shorter period of time.

An even smaller number of patients have naturally occurring antibodies to Botox, which is most likely due to an exposure to botulinum toxin in food. I’ve encountered 4 or 5 such patients and a couple of them who did go on to try Myobloc, did not respond to it either.

When Botox stops working despite providing good muscle relaxing effect, it could be because the headaches have changed in character, severity or are being caused by a new problem. It could be due a sudden increase in stress level, lack of sleep, hormonal changes, drop in magnesium level due to a gastro-intestinal problem, or another new illness, such as thyroid disease, diabetes, multiple sclerosis, or increased pressure in the brain. Such patients need to be re-evaluated with a neurological examination, blood tests, and usually an MRI scan. One of my patients who was doing well on Botox for several years, did not have any relief from her last regular treatment. Since she had no obvious reasons why her migraines should stop responding to Botox, I ordered an MRI scan. Unfortunately, she turned out to have brain metastases from breast cancer which had not yet been diagnosed.

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Cluster headache is one of the most painful conditions that has lead some patients call it a suicide headache. A new observational study done by researchers at the Eli Lilly company and Stanford University was presented at the recent annual scientific meeting of the American Headache Society.

Considering that cluster headaches are relatively rare, the major strength of this study is its size – 7589 patients. These patients were compared to over 30,000 control subjects without headaches. We’ve always known that cluster headaches are more common in men with previous studies indicating that male to female ratio is between 5:1 and 3:1. However, only 57% of patients in this new report were males. This does not reflect my experience – I see at least five times as many men as women. It is possible that I underdiagnose cluster headaches in women or the study used unreliable data. In fact, the study data was collected from insurance claims, so I suspect that the truth is closer to my experience and to the older published data.

The study did find that thoughts of suicide were 2.5 times more common in patients with cluster headaches compared to controls, while depression, anxiety and sleep disorders were twice as common. Cluster headache patients also were 3 times more likely to have drug dependence. The most commonly prescribed drugs were opiates (narcotics) in 41%, which partially explains high drug dependence rates, steroids, such as prednisone (34%), triptans, such as sumatriptan (32%), antidepressants (31%), NSAIDs (29%), epilepsy drugs (28%), blood pressure drugs, such as verapamil (27%), and benzodiazepines, such as Valium or Xanax (22%).

It is very unfortunate that over a period of one year only 30% of patients were prescribed drugs recommended for cluster headaches. We know that narcotics and benzodiazepine tranquilizers are not very effective and can lead to dependence and addiction. Drugs that are effective include a short course of steroids (prednisone), sumatriptan injections, blood pressure drug verapamil (often at a high dose), some epilepsy drugs and occasionally certain antidepressants. The report did not mention oxygen, which can stop individual attacks in up to 60% of cluster headache sufferers. Nerve blocks and to a lesser extent, Botox injections can also provide lasting relief. It is possible that the data on oxygen, nerve blocks and Botox was not available.

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Cluster headaches are much less common than migraines (less than a million vs 36 million sufferers), but are arguably the most painful type of headaches a man can experience. And it is usually a man because cluster headaches are thought to be 3-5 times more common in men. However, a study just published in Neurology suggests that the ratio of men to women is closer to 2:1.

This study by Danish researchers also established that women suffering from cluster headaches are more often misdiagnosed than men – 61% vs 46%. Consequently, it takes a year longer for a woman to be diagnosed than for a man – 6.5 years vs 5.5 years. But considering how devastating these headaches can be, these numbers are terrible for both sexes.

Cluster headaches get their name from the fact that they occur in clusters – daily or more frequent attacks lasting one to three hours for a period of a month or two, each year and often at the same time of year. One surprising finding of the study is that women are more likely to have chronic cluster headaches (no break from attacks for more than a month) – 44% vs 32%.

The reason for such high rates of misdiagnosis and long delays in diagnosing cluster headaches is that it is a relatively rare type of headaches and that it is easy to mistake cluster for a migraine or a sinus headache. Cluster headache is always one-sided and centers in the eye, which is common with migraines. It is usually accompanied by a runny nose (and tearing with redness of the eye) as occurs with a sinus headache.

But cluster headaches also have very distinctive features that should make the diagnosis easy, if only doctors asked a few questions. I’ve had a fair number of patients who diagnosed themselves after being misdiagnosed by doctors. During a cluster attack patients tend to be restless, pacing around, hitting their fist or even their head against walls, and sometimes screaming from pain, while migraine sufferers tend to stay very quiet since every movement, sound, and light worsen the pain. The fact that these occur every night for an hour or two and then resolve on their own is also a telltale sign. Migraine pain lasts for at least 4 hours and often for a couple of days without a break. Sinus headaches do not come and go and are easy to rule out by a CAT scan, a standard equipment in every emergency room and cluster sufferers do often end up in an ER.

Fortunately, once the correct diagnosis is made, cluster headaches can be treated very effectively in most patients. Some of the treatments overlap with migraines, such as sumatriptan injections, magnesium infusions, occipital nerve blocks, and Botox injections, but other help only cluster headaches. These include a 10-day high-dose course of steroids, oxygen inhalation, high-dose verapamil, lithium, and other.

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According to large epidemiological studies, migraine sufferers are 2-3 times more likely to develop depression, anxiety and other psychiatric disorders than those without migraines. And it is a bidirectional relationship, meaning that those with depression are 2-3 times more likely to develop migraines than those without depression. Cluster headaches, which have at times been referred to as “suicide headaches,” have been suspected to be also associated with depression. Until now, no similar large studies have been conducted in patients with cluster headaches in part because cluster headaches are much less common than migraines.

In a study just published in the journal Neurology, a group of Dutch physicians studied 462 patients with cluster headaches and compared them to 177 control subjects. They evaluated these patients for history of depression during their lifetime, current depression in the midst of a cluster period, and because many cluster attacks occur in sleep, they also looked for sleep disturbances. The results showed that depression was 3 times more likely to occur patients with cluster headaches than in healthy controls. Those with chronic cluster headaches had a higher risk of depression and sleep problems than patients with episodic cluster headaches. Current depression was associated with having active attacks within the preceding month, but this association was only present if the patient also had a sleep disturbance.

The authors concluded that cluster headache patients are three times more likely to develop depression in their life time. However, current depression was in part related to sleep disturbances due to ongoing nocturnal cluster attacks.

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My most commented on blog post (over 150 comments) is on the daily use of triptans. A new report confirms the safety of long-term daily use of sumatriptan injections in cluster patients. Cluster headaches are arguably the most severe type of headaches and the name comes from the fact that they tend to occur in clusters lasting several weeks to several months. However, in some patients headaches become persistent without any remissions and then they are called chronic cluster headaches. The only FDA approved treatment for cluster headaches is injectable sumatriptan (Imitrex). Most patients have one cluster attack in 24 hours, but some have many. A report mentioned in one of my other previous blogs describes a woman (although men are more commonly affected by cluster headaches) who has been injecting sumatriptan daily on average 20 times a day for 15 years.

A recent report by Massimo Leone and Alberto Cecchini is entitled, Long-term use of daily sumatriptan injections in severe drug-resistant chronic cluster headache.

The authors investigated occurrence of serious side effects in patients with chronic cluster headaches who were using sumatriptan injections continuously at least twice daily (the official limit) for at least 2 years. They found fifty three such patients with chronic cluster headaches seen in their clinic between 2003 and 2014. During the 2-year period, all patients were carefully followed with regular visits at their center. Headaches and sumatriptan consumption were recorded in headache diaries. Patients were questioned at each visit about serious side effects and had at least two electrocardiograms. Brain MRI was normal in all patients. None of the patients had a history of stroke, TIA, ischemic heart disease, myocardial infarction, or arrhythmia, or diseases affecting systemic vessels.

In the 2-year study period, no serious side effects were observed and no patients needed to discontinue sumatriptan use. No electrocardiogram abnormalities were found. All patients needed a full dose (6 mg) of sumatriptan injection (prefilled syringes with 4 and 6 mg available). At the end of the study period, 42% noticed some reduction in the efficacy of sumatriptan injections both in terms of time of onset of effect and on pain intensity, but still considered the drug their first choice to treat the attacks.

In the study period, 36 of the 52 patients (69%) used more than 12 mg of sumatriptan in 24 hours (maximum 36 mg in 24 hours) but no increase in number or severity of side effects was observed during the course of the study. Complete loss of efficacy was not reported by any of the patients.

The authors mention that since the launch of sumatriptan injections in 1992 and until 1998, approximately 451 serious cardiac side effects have been reported to occur within 24 hours after administration of sumatriptan injections, tablets or nasal spray, but this is out of more than 236 million migraine attacks and more than 9 million patient exposures between 1992 and 1998. The majority of patients who developed serious cardiac events within 1 to 3 hours of sumatriptan administration had risk factors for coronary artery disease.

The authors concluded that their results showed that long-term daily sumatriptan use in patients free of heart disease did not cause serious side effects and this is in line with observations from previous studies.

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Solar activity is high again – NASA’s Solar Dynamics Observatory reported a flare on October 1. And in the past two weeks we’ve been seeing many more patients whose cluster headaches returned. The last time we had a surge in the number of cluster patients was last October, when solar activity was also high (see this post).

Unfortunately, there is not a lot we can do about the solar activity, but we do have many treatment options for cluster headaches. These include intravenous magnesium (40% of cluster headache sufferers are deficient), occipital nerve blocks, steroids, daily prevention with verapamil, Botox injections, oxygen inhallation, nasal spray of zolmitriptan (Zomig NS), and sumatriptan (Imitrex) injections. For most cluster patients one more often several of these treatments provide good relief. If these are ineffective, we also use drugs such as lithium, topiramate, and even an herbal supplement, Boswellia.

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Fluctuations in the female hormone estrogen have been proven to be involved in triggering menstrual and perimenopausal migraine headaches. Testosterone levels have been reported to be low in men and women with cluster headaches. Testosterone replacement therapy seems to help these patients, when other standard treatments for cluster headaches do not.

A study presented at the recent annual meeting of the American Headache Society reported on testosterone levels in men with chronic migraine headaches. A significant percentage of men with chronic migraines also have low testosterone levels. This study did not look at the effect of testosterone replacement therapy, but it is possible that it may help chronic migraine sufferers as it does those with cluster headaches. It seems prudent to check testosterone level in men with chronic migraine headaches who do not respond to standard approaches such as medications, Botox injections, magnesium, and other treatments. And if the level is low, replacement therapy should be tried.

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We are again in a cluster season. We do not see any cluster headache patients for months and then dozens come in within weeks. It is not allergies, barometric pressure or any other earth phenomena that trigger cluster headaches in so many people at once. It has been speculated that solar activity may be the trigger and I just checked the NASAs Solar Dynamics Observatory website and found that the sun has “active regions galore”. I wrote about solar activity as a possible culprit last October when we had another wave of cluster patients. Unfortunately, there is not much we can do about the sun, but we do have many effective treatments for cluster headaches, including intravenous magnesium, occipital nerve blocks, oxygen, injectable sumatriptan, verapamil, and for chronic cluster headaches, Botox injection.

A recent study by British neurologists in the journal Headache described the severe impact of cluster headaches on quality of life and neuro-psychological symptoms. The researchers found that cluster headache patients had normal intelligence and executive functions, but had worse working memory, disturbance of mood, and poorer quality of life compared with healthy controls. Similar findings have been found in patients with other chronic pain conditions as well. It is most likely that cognitive impairment and mood changes can be reversed with effective treatment of pain.

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Cluster headaches cause more severe pain than any other type of headaches. Some patients even call them suicide headaches because they provoke thoughts of suicide. The name comes from the fact that they occur in clusters – every day for a couple of months and then they go away for a year or longer. In those with chronic cluster headaches they never go away. The headaches are brief – anywhere from 30 minutes to 3 hours. They are always one-sided, with pain usually around the eye, and are accompanied by tearing, nasal congestion, and sometimes restlessness. More men than women suffer from them.

Treatment of cluster headaches can be very effective. A 10-day course of prednisone or an occipital nerve block can abort the entire cluster. We also have preventive drugs, such as a blood pressure medicine, verapamil (used in high doses), epilepsy drugs, and lithium. These are taken daily to prevent headaches. To treat individual attacks, inhalation of 100% oxygen under high flow, zolmitriptan nasal spray (Zomig NS), and sumatriptan (Imitrex) injections can be true life savers.

Some of the alternative therapies that have been reported to help include melatonin, intranasal capsaicin (hot pepper extract), and an herbal product, Boswellia (Nature’s Way is a good brand for herbals).

Unfortunately, there are some cluster headache sufferers who do not respond to any of these treatments. We even treated some patients with intravenous histamine, which requires hospital admission and two of my patients were implanted with a vagus nerve stimulator (with good relief).

Some cluster patients have been found to have low testosterone levels and treating them with testosterone seems to help.

This testosterone connection led to trials of a fertility drug, clomiphene citrate (Clomid). Clomiphene enhances testosterone production and binds to hypothalamic estrogen receptors, which is why it was considered as a treatment for cluster headaches. A second case of successful treatment of cluster headaches with Clomid has just appeared in the journal Headache. This was a case of a 65-year-old man with a 17-year history of chronic cluster headaches who did not respond or had significant side effects to many cluster headache preventive medications including verapamil, lithium, valproic acid, topiramate, baclofen as well as greater occipital nerve blocks and inpatient hospitalization.

The patient experienced 3-5 headaches per day. On Clomid (100 mg/day) he became 100% pain-free and remained so for three and half years with only mild fatigue as a side effect. He then had cluster headache recurrence and did well on gabapentin for another 3 years, but then his headaches returned. Clomiphene was restarted, and he became pain-free once again.

Clomid should be considered when the usual preventive drugs for cluster headaches are ineffective.

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Cluster headaches usually occur once or twice a year for a period lasting from a few weeks to a few months. During those periods, they occur daily or more than once a day. Interestingly, these episodes of cluster headaches tend to occur at the same time of year in many patients, but not always at the same time of year. Looking at our data, we have found that in some years many cluster patients developed their attacks in August, another year, in November, and this year, it has been September – October. This year, we are also seeing many patients whose cluster headaches are not responding to usual treatments.

It does not appear that barometric pressure or allergies are responsible for triggering cluster headaches. One unsubstantiated theory is that the solar activity is responsible for bringing on cluster headaches. This report in the Wall Street Journal indicates that we are currently going through a period of an unusually intense solar activity. Perhaps this is why some of our cluster patients are having unusually severe headaches.

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Cluster headache patients have been coming to our office in increasing numbers in the past few weeks. We seem to be in a cluster season – many patients with cluster headaches come within the same month or two and then, for several months we see very few cluster patients. Many cluster headache sufferers ask about the efficacy of LSD, hallucinogenic mushrooms and seeds.

The use of hallucinogens for cluster headaches was first reported by a Scottish man in 1998. He started using LSD for recreation and for the first time in many years had a year without cluster headaches. The first report in scientific literature appeared in 2006 in the journal Neurology. Dr. Sewell and his colleagues surveyed 53 cluster headache sufferers, of whom 21 had chronic cluster headaches. Half of those who tried LSD reported complete relief.

Researchers are trying to study a version of LSD (brominated LSD) that does not cause hallucinations. This form of LSD was reported in the journal Cephalalgia to stop cluster attacks in all five patients it was given to. It is not clear if any additional studies are underway, but one American doctor, John Halpern is trying to bring this product to the market in the US.

Trying to obtain LSD or hallucinogenic mushrooms carries legal risks, including incarceration. According to Dr. McGeeney, who is an Assistant Professor at Boston University School of Medicine, it is legal to buy, cultivate, and sell seeds of certain hallucinogenic plants, such as Rivea Corymbosa, Hawaiian baby woodrose, and certain strains of morning glory seeds. However, it is not legal to ingest them.

The bottom line is that I urge my patients not to try hallucinogens because their safety has not been established. This is especially true for illicit products, which may contain additional toxic substances.

Fortunately, we do not need to resort to these agent because we have such a variety of safer and legal products. These include preventive medications, such as verapamil in high doses, topiramate, lithium, and for chronic cluster headaches, Botox injections. None of these drugs are approved by the FDA and are not likely to be approved because this is a relatively rare condition, which makes performing large studies very difficult. The only FDA-approved drug for cluster headaches is an abortive drug, injectable sumatriptan (Imitrex).

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Botox injections are currently approved for the treatment of chronic migraines but not cluster headaches. However, my experience at the New York Headache Center suggests that Botox injections may also help relieve cluster headaches, which some call suicide headaches. We inject Botox for cluster headaches in a similar way we do for chronic migraines, that is the injections are given in the forehead, temple and back of the head and neck. One difference is that since cluster headaches are strictly one-sided we inject only one side with the exception of the forehead because injecting only one side of the forehead will result in a lopsided appearance.

Researchers at the Norwegian University of Science and Technology in Oslo came up with an idea of injecting Botox into the sphenopalatine ganglion. This ganglion is a bundle of nerve cells that sits behind the back of the throat and has been a target for all kinds of procedures to relieve various pain problems. Doctors have attempted numbing those cells with cocaine and lidocaine, destroying it with heat, and stimulating it with electric current in an attempt to relieve not only cluster and migraine headaches but a range of painful conditions, including low back pain. Unfortunately, we do not have any good scientific studies proving that any of these procedures on the sphenopalatine ganglion work for any condition it’s been tried for. We have many so called anecdotal reports describing successful cases, but no large controlled trials have ever been performed.

It is not clear why the Norwegian doctors think that injecting Botox into the ganglion will be effective, beyond the fact that Botox “can stops the flow of impulses along the nerves”. A report in says that “The researchers strongly believe in their treatment method, in part because a new study unrelated to their work has shown an effect by using an electric current to paralyse the nerve bundle.” So far it does not seem that they’ve treated any patients, but did start recruiting patients for a study.

They hope to enroll 30-40 cluster headache patients and then another 80 with migraine headaches. also reports that the treatment uses an MRI of the patient’s head to make certain that the surgeon knows exactly where the nerve bundle is. A navigation tool, composed of three small spheres on the pistol, and a plate with three spheres mounted on the patient’s head, enables the surgeon to find the nerve bundle using the MRI image. “A computer sends light signals to all the spheres to form precise points. We don’t miss, but anyone who wants to participate in the study must accept the risk that it could happen, because this has never been done before. If the Botox hits an area near the nerve bundle, it could cause temporary double vision, or weaken the ability of the patient to chew,” says the lead researcher, Dr. Tronvik.

Until we have some evidence that this treatment works we have to work with the standard approaches to cluster headaches, which include, occipital nerve blocks, oxygen, a course of steroid medications, sumatriptan (imitrex) injections, verapamil, lithium, and other drugs. Two of my patients for whom none of these approaches and Botox injections worked did respond to vagus nerve stimulation, or VNS. This procedure involves wrapping a wire around the vagus nerve in the neck and connecting it to a pacemaker-like device which is implanted under the skin in the upper chest. This is also a totally unproven method with only anecdotal evidence. However, VNS has been approved by the FDA for difficult to treat epilepsy and depression. Considering that antidepressants and epilepsy drugs help migraine and cluster headaches, it is logical to conduct studies of VNS before going for a more invasive procedures.

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Stimulation of the sphenopalatine ganglion seems to relieve cluster headaches according to a study by European neurologists. The study examined the efficacy of the on-demand sphenopalatine(SPG) stimulation in chronic cluster headache patients. 43 patients in this randomized controlled study were implanted with the ATI Neurostimulator System. Chronic cluster headache is a disabling neurological disorder that often does not respond to medical therapy. A previous study showed that this stimulator was effective for acute cluster headache pain relief and in some patients made their attacks less frequent. These patients also had clinically and statistically significant improvement in quality of life and reduction in headache disability.

The 43 patients in the current study were dissatisfied with their cluster headache treatment and 32 of them completed the one-year study with 23 continuing to use the stimulator beyond one year. At enrollment, 18 (78%) of patients indicated their overall evaluation of the ATI Neurostimulation System for treating their chronic cluster headaches as good or very good. 18 (78%) found SPG stimulation a useful therapy in treating their cluster headaches. 19 (83%) found surgical effects tolerable and the implanted neurostimulator comfortable or did not notice it and 23 (100%) found the stimulation sensation tolerable. 15 (65%) did not have significant side effects after stimulation. 21 (91%) would make the same decision again to treat their CH with the ATI Neurostimulation System, and 22 (96%) would recommend the ATI Neurostimulation System to someone else. 13 (57%) of patients experienced clinically significant improvement in headache disability and quality of life compared to baseline.

These results suggest that SPG stimulation with the ATI Neurostimulator is an effective therapy with sustained benefits and a high level of
patient satisfaction. This is an experimental device and is not available in the US. Even when it becomes available it would be more reasonable to try less invasive, even if not proven treatments, such as Botox injections. My experience treating chronic cluster headaches with Botox is only “anecdotal” (as opposed to that from large clinical trials) and involves a small number of patients, but nevertheless it has been very positive.

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Oxygen inhalation is a proven method of treating cluster headaches. The patient usually rents a large oxygen tank and breathes in pure oxygen through a mask whenever he gets an attack (it is usually a he since 5 times as many men suffer from cluster headaches as women). Demand valve oxygen (DVO) is a promising new oxygen delivery system for the acute treatment of cluster headaches, according to a recent report by Dr. Todd Rozen.

DVO delivers oxygen to the user as soon as they inhale from an attached mask and the amount of oxygen is controlled by how fast they are breathing. DVO is capable of delivering much more oxygen than by just breathing it through a regular mask. In the study 3 patients tried both DVO and a regular mask. All patients had chronic cluster headaches. On DVO all 3 subjects became pain free; 2 of 3 became pain free on a regular mask, while the third subject needed 30 minutes to get to mild pain. Patients using DVO became pain free faster than when a regular mask was used. This was a very small sample and bigger studies are needed, but DVO appears to be at least as effective for acute treatment for cluster headaches as inhalation of oxygen through a regular mask.

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A new treatment developed by Belgian neurologists was reported to help patients with chronic refractory cluster headaches. The name cluster headaches originates from the fact that headaches occur in clusters, typically once a year for a period of a month or two, during which headaches occur daily. Unfortunately, in some patients cluster headaches are chronic and occur continuously. Some of these chronic cluster patients respond to medications, such as verapamil, topiramate, lithium or Botox injections. A small number of patients fails to respond to any of the usual therapies and are considered refractory to treatment. Because the pain of cluster headaches is extremely severe and because headaches occur daily and often more than once a day these patients often become despondent. Out of desperation, doctors have tried different unproven and at times risky treatments, such as deep brain stimulators with electric probes implanted deep into the brain. This is obviously a very invasive procedure that has resulted in strokes and deaths. I have treated two patients with a much less invasive Vagus Nerve Stimulator and these two responded well.
Dr. Jean Schoenen and his colleagues implanted 28 patients with chronic refractory cluster headaches with a miniature neurostimulator implanted in the back of the nasal cavity, near the sphenopalatine ganglion. This ganglion has been injected and anesthetized (with lidocaine and cocaine) in an attempt to relieve various pains for many years. The stimulator was implanted by a neurosurgeon in an out-patient visit and the procedure leaves no visible scar. Once implanted, the device can be activated by a remote controller which the patient holds near the face. The study was blinded in that some patient were given either very mild or no stimulation at all. The researchers hoped that by stimulating sphenopalatine ganglion for 90 seconds patients would be able to stop a cluster attack. The results showed that only 7 (25%) of patients were able to abort an attack, but surprisingly another 10 (36%) reported that after trying to treat 30 attacks (over 3 – 8 week period) the frequency of their attacks dropped by more than 50%. Headache-related disability improved in 64% of patients. Patients were allowed to use acute medications to stop individual attacks and only 31% of those who received real stimulation used them, while these drugs were used by 78% of those given mild or no stimulation. The most common side effect was an unpleasant sensation in the face, experienced by 81% of patients but these symptoms resolved within 3 months. Two patients had infections and another two had their stimulator drift out of place and had to have it removed. The stimulator is known as ATI Neurostimulator System and it does not preclude having MRI scans done in these patients. The manufacturer of this device launched a large multi-center trial of this device in Europe, both for chronic cluster and disabling migraine headaches.
sphenopalatine ganglion

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