New treatments | Headache NewsBlog

Predicting response to Botox injections

By: Dr. Mauskop

01-04-2014

A good predictor of response to Botox injections in chronic migraine patients has been found by Spanish researchers.

While Botox is a very effective treatment for chronic migraines and possibly other types of headaches and pain, it does not help everyone. Approximately 30% of patients with chronic migraine headaches do not respond to Botox. We usually try at least two sets of injections three months apart before considering the patient to be a non-responder. Considering that Botox is an expensive treatment, it would be very useful to know beforehand which patients will respond and which will not. Besides the cost, it would also save patients time, during which they could be trying other treatments.

Some studies show that having a constricting headache or pain in the eye is usually a positive predictor of response to Botox. On the other hand, exploding headache (that is when the pain is felt pushing from the inside out), is less likely to respond to Botox injections. However, these are very subjective descriptions and predictions based on them are not that reliable.

A new study by Spanish researchers just published in the journal Headache reported that the levels of CGRP (calcitonin gene-related peptide) and VIP (vasoactive intestinal peptide) in patients’ blood are good predictors of response to Botox in chronic migraine sufferers. These two chemicals, which circulate in the blood and perform various important functions in the brain have long been the subject of scientific research. Actually, we think that Botox works by blocking the release of CGRP from the peripheral nerve endings. Dr. Julio Pascual and his colleagues measured the levels of these two chemicals in chronic migraine patients before they were treated with Botox. Botox was administered according to the standard protocol every 12 weeks for at least two treatment cycles. A patient was considered a moderate responder when both: 1) moderate-severe headache episodes were reduced by between 33 and 66%; and 2) subjective benefit on a visual scale from 0 to 100 was recorded by the patient of between 33-66%. Patients were considered to be excellent responders when both items improved by more than 66%. Those without improvement of at least one-third in the two items were considered as nonresponders.

The study involved 81 patients with chronic migraine and 33 healthy controls. CGRP and VIP levels were significantly increased in the chronic migraine population vs controls. CGRP and, to a lesser degree, VIP levels were significantly increased in responders vs nonresponders. The probability of being a responder to Botox was 28 times higher in patients with a CGRP level above the threshold.

The measurement of CGRP and VIP is done only by research institutions and is not yet offered by commercial laboratories. However, considering how much money can be saved by not giving Botox to those who are unlikely to respond, these tests should become widely available once these findings are confirmed by other researchers.

Topiramate (Topamax) is approved by the FDA for adolescents.

By: Dr. Mauskop

29-03-2014

Headache medications, New treatments

Yesterday, the FDA approved the first preventive (prophylactic) treatment for migraines in adolescents – kids between the ages of 12 and 17. Topamax (topiramate) was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.
As the FDA stated in its announcement, “Migraine headaches can impact school performance, social interactions, and family life. Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices.”
The announcement also stated that “About 12 percent of the U.S. population experiences migraine headaches. Migraine headaches are characterized by episodes of throbbing and pulsating pain in the head, and may occur several times per month. Other common symptoms include increased sensitivity to light, noise, and odors, as well as nausea and vomiting. Many patients experience their first migraine attack before reaching adulthood, and migraine can be just as disabling in teens as it is in adults.

The safety and effectiveness of Topamax in preventing migraine headaches in adolescents ages 12 to 17 was established in a clinical trial that enrolled 103 participants. Those treated with Topamax experienced a decrease in the frequency of migraine of approximately 72 percent compared to 44 percent in participants that took an inactive drug (placebo).

The most common adverse reactions with the approved dose of Topamax (100 milligrams) were paresthesia (a burning or prickling sensation felt in the hands, arms, legs, or feet), upper respiratory infection, anorexia (loss of appetite), and abdominal pain.

Topamax increases the risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women who take the drug during pregnancy. The benefits and risks of Topamax should be carefully weighed before using it in women of childbearing age. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used.”

It is a little surprising that the FDA based its approval on such as small study – 103 patients. I should add that topiramate can also cause cognitive side effects, such as memory and word retrieval problems in a significant percentage of children and adults. Approximately 20% of adults taking topiramate for more than a year or two develop kidney stones. This most likely can also happen in children. As you can tell from this and my previous posts, I am not a big fan of Topamax. In kids particularly we begin with life style and dietary changes, biofeedback, magnesium, CoQ10 and other supplements and even Botox injections, which are very safe, before resorting to prophylactic drugs such as topiramate.
Julie Mauskop
Art credit: JulieMauskop.com

More evidence that Botox relieves not only migraine headaches, but also depression.

By: Dr. Mauskop

21-03-2014

New treatments

The beneficial effect of Botox on mood has been reported for years. I mentioned this in one of my blog posts in 2011. Now, a new and highly scientific study (double-blind, placebo-controlled) which is about to be published in the Journal of Psychiatric Research confirms that Botox relieves depression. The study is described in today’s New York Times.

I have also heard from many of my own patients who receive Botox for chronic migraines that their mood improves, although in their case it could be to a great extent because their headaches improve.

What to ask for if your migraine lands you in the emergency room.

By: Dr. Mauskop

19-03-2014

Headache medications, Headaches, New treatments

A severe migraine attack can sometimes land you in an emergency room. With its bright lights, noise, and long waits, it is the last place you want to be in. To add insult to the injury, some doctors will think that you are looking for narcotic drugs and treat you with suspicion, while others will offer ibuprofen tablets. It is hard to think clearly when you are in the throes of a migraine, so you need to be prepared and have a list of treatments you may want to ask for, just in case the ER doctor is not good at treating migraines.

If you are vomiting, first ask for intravenous hydration and insist on having at least 1 gram of magnesium added to the intravenous fluids. Everyone with severe migraines should have sumatriptan (Imitrex) injection at home since it often eliminates the need to go to an ER in the first place. If you haven’t taken a shot at home, ask for one in the ER. The next best drug is a non-narcotic pain medicine, ketorolac (Toradol) and if you are nauseous, metoclopramide (Reglan). Do not let the doctor start your treatment with divalproex sodium (Depakene, drug similar to an oral drug for migraine prophylaxis, Depakote) or opioid (narcotic drugs) such as demerol, morphine, hydromorphone and other.

This post was prompted by an article just published in the journal Neurology by emergency room doctors at the Montefiore Hospital in the Bronx. It was a double-blind trial which compared intravenous infusion of 1,000 mg of sodium valproate with 10 mg metoclopramide, and with 30 mg ketorolac. They looked at relief of headache by 1 hour, measured on a verbal 0 to 10 scale. They also recorded how many patients needed another rescue medication and how many had sustained headache freedom.

Three hundred thirty patients were enrolled in the study. Those on divalproex improved by a mean of 2.8 points, those receiving IV metoclopramide improved by 4.7 points, and those receiving IV ketorolac improved by 3.9 points. 69% of those given valproate required rescue medication, compared with 33% of metoclopramide patients and 52% of those assigned to ketorolac. Sustained headache freedom was achieved in 4% of those randomized to valproate, 11% of metoclopramide patients, and 16% receiving ketorolac. In the metoclopramide arm, 6% of patients reported feeling “very restless”, which can be a very unpleasant side effect of this drug.

The authors concluded that the valproate was less efficacious than either metoclopramide or ketorolac. Metoclopramide was somewhat better than ketorolac but it also had more side effects.

To summarize, ask the doctor to start with hydration and magnesium, then sumatriptan injection, followed by metoclopramide and ketorolac, if needed. If the above treatments do not help, we also give dexamethasone (Decadron, a steroid medication) and DHE-45 (dihydroergotamine). All these medications can be administered in the office and we always tell our patients not to go to an ER and to come into the office if the attack occurs during our office hours.

Invasive treatments for trigeminal neuralgia

By: Dr. Mauskop

05-03-2014

New treatments, Trigeminal and other neuralgias

Trigeminal neuralgia (TN) is an excruciatingly painful disorder which affects about one in a thousand people. Patients describe the pain of TN as an electric shock going through the face. Eating and talking often triggers the pain, so some patients become malnourished and depressed. The pain is brief, but can be so frequent and severe that it causes severe disability, weight loss, severe anxiety, and depression. The good news is that most people can obtain relief by taking drugs, such as Tegretol (carbamazepine), Trileptal (oxcarbazepine), Dilantin (phenytoin), or Lioresal (baclofen). I have successfully treated several patients who did not respond to these medications with Botox injections.

Patients who do not respond to medications or Botox injections have several surgical options available. According to a new Dutch “Nationwide study of three invasive treatments for trigeminal neuralgia” published in journal Pain shows that every year about 1% of those suffering from TN undergo surgery. Of the three most common types of surgery, percutaneous radiofrequency thermocoagulation (PRT) is by far most popular – in a three year period in Holland, 672 patients underwent PRT, 87 underwent microvascular decompression (MVD), and 39 underwent partial sensory rhizotomy (PSR). The latter two procedures a performed by neurosurgeons (MVD requires opening of the skull), while PRT is usually done by anesthesiologists (a probe is inserted through the cheek to the nerve ganglion under X-ray guidance). MVD was most effective, but caused more complications than PRT, although fewer than with PSR. More patients having PRT had to have a repeat procedure, but it was still safer than the other two. Very often the physician under-treats during the first treatment of PRT in order to avoid complications. Overall, the best initial procedure for those suffering with TN is PRT and if repeated PRTs fail, MVD can often cure this condition.

A new device is approved to treat migraine with aura.

By: Dr. Mauskop

15-12-2013

Alternative Therapies, New treatments

Transcranial magnetic stimulation (stimulation of the brain with a magnetic field) has been researched for over 30 years. It has been used to study the brain and to treat a variety of conditions, such as depression, Parkinson’s, strokes, pain, and other. The U.S. Food and Drug Administration has “allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.”

Here is an excerpt from the FDA News Release:

“The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.

The FDA reviewed a randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 percent of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present. Analysis of these 113 subjects was used to support marketing authorization of the Cerena TMS for the acute treatment of pain associated with migraine headache with aura.

The study showed that nearly 38 percent of subjects who used the Cerena TMS when they had migraine pain were pain-free two hours after using the device compared to about 17 percent of patients in the control group. After 24 hours, nearly 34 percent of the Cerena TMS users were pain-free compared to 10 percent in the control group.”

The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea. The device is for use in people 18 years of age and older. The study did not evaluate the device’s performance when treating types of headaches other than migraine headaches preceded by an aura.

Adverse events reported during the study were rare for both the device and the control groups but included single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning). Dizziness may be associated with the use of the device.

Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. The recommended daily usage of the device is not to exceed one treatment in 24 hours.”

After 30 years of research we know that the risks of TMS are minimal, although theoretically, TMS induces an electric current in the brain, similarly to what happens with electric shock therapy, but to a much milder degree. TMS treatment of migraines does not appear to cause memory or any other problems seen with electric shock therapy for depression.

The main problem with this device is that it is bulky and inconvenient to carry around. It will probably will be reserved for people who have severe migraines that do not respond to preventive and abortive medications and Botox injections and cause disability. Considering its inconvenience, cost, and the fact that only 15% to 20% of migraine sufferers have auras (most of whom can be treated with medications or Botox), this device is not likely to be used widely. But for those for whom it works, it could be life changing.

Photo credit: www.eneura.com

A new way to adminster Botox for cluster and migraine headaches

By: Dr. Mauskop

04-11-2013

Cluster headaches, New treatments

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 StudyNordic.com 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. ScienceNordic.com 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.

Art credit: JulieMauskop.com

Cost of Botox injections for migraine headaches

By: Dr. Mauskop

02-10-2013

Headache medications, New treatments

Botox injections is the only FDA-approved treatment for chronic migraine headaches. This is a very effective (works in 70% of chronic migraine patients) and very safe treatment. The only major drawback is its cost. However, there is a great variation in the cost from doctor to doctor and hospital to hospital. This post was prompted by an email I received from a former patient. Here are some excerpts from our exchange (with her permission):

“You’ve been my doctor now for many years, and I was just in your office over the summer for Botox treatment, but I live now in Charlottesville, VA and UVA’s hospital down here charges around $6000 for the same procedure that your office can do for $2250. With my insurance, I’m still responsible for 20% of the bill, and I can’t afford to have the procedure done here in Charlottesville.

They tell me it’s because they’re paying for facilities and staff, but even the drug is more than twice as much…THAT doesn’t make sense at all! This treatment has changed my life quite dramatically for the better. I’m so much healthier, more productive, creative, and all around a better citizen and human being as a result of not having constant headaches.”

Part of my response to her: “I am not surprised about the $6,000 price tag – I recently gave a lecture at Harvard and they also charge $6,000 and so do Mayo and Cleveland Clinics. They all also charge $2,000 for IV magnesium, while we charge $250.”

Our out-of-pocket fee for Botox injections is often only $1,700 and sometimes less, depending on the amount of Botox injected. However, the majority of our patients are covered by insurance and they have to pay only their usual copay. Almost all insurance plans now pay for Botox injections for chronic migraines, although they often require trials of prophylactic medications before they approve Botox.

Art credit: JulieMauskop.com

Botox relieves hemiplegic migraine.

By: Dr. Mauskop

08-08-2013

New treatments, Science of Migraine

Surprisingly, Botox appears to relieve hemiplegic migraines, according to a report by two neurologists from the Mayo Clinic.

They describe 5 female patients who suffered from very frequent and severe migraine headaches with four of them having chronic migraines, that is had headaches on 15 or more days each month. The headaches were preceded and/or accompanied by weakness of one side of their body. The weakness lasted only 20 minutes in one patients, but for hours and days in others. All five patients were first treated with prophylactic medications, which either did not help or caused unacceptable side effects. Botox injections were given every 3 months into the usual sites around the scalp, neck and shoulders. A total dose of 150 units was injected. Three of the patients had three sets of injections by the time of this report and they continued to respond well.

Migraine with typical visual auras has been reported to respond well to Botox injections, which is also somewhat surprising since Botox appears to work on the sensory nerves. This effect on sensory nerve endings leads to the relief of pain. It is likely that reducing painful episodes in turn leads to a calming effect on the brain in general and the brain stops generating migraines as well as symptoms associated with migraines.

I have also seen many patients with visual, sensory and motor aura respond well to Botox injections, often when prophylactic drugs had been ineffective.

Art credit: JulieMauskop.com

Electrical stimulator for cluster headaches.

By: Dr. Mauskop

23-07-2013

Cluster headaches, New treatments

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.

Art credit: JulieMauskop.com

Frequent migraines are not different from chronic migraines

By: Dr. Mauskop

19-06-2013

New treatments, Science of Migraine

Botox is approved by the FDA for the prophylactic treatment of chronic migraine headaches. Chronic migraine was arbitrarily defined by headache researchers as headache occurring on more than 14 days each month. Epidemiological research by Dr. Richard Lipton and his colleagues at the Albert Einstein School of Medicine suggests that there is no biological difference between frequent migraines that occur on 10 or more days each month and chronic migraines.

They compared clinical features and the incidence of other chronic medical conditions in three groups of patients with migraine: low frequency (0-9 days/month), high frequency (10-14 d/mo) and chronic migraine (15-30 d/mo). The American Migraine Prevalence and Prevention Study is a US-population-based study with 16,573 people with migraine who responded to a 2005 survey. Of these, 10,609 had low frequency, 640 had high frequency and 655 had chronic migraines. Rates of pulmonary and respiratory conditions including asthma, bronchitis, chronic bronchitis, emphysema/COPD, allergies/hay fever, and sinusitis increased across headache frequency groups and were significantly different for chronic migraine vs. low frequency, but not for chronic migraine vs. high frequency. A similar finding was seen for cardiac conditions and strokes. Depression, nervousness or anxiety, bipolar disorder/mania, and chronic pain were also much more common and similar in those with frequent or chronic migraine compared to those with low frequency migraines (around 30% vs 15%-18%).

These findings suggest that patients with frequent migraines resemble those with chronic migraines much more than they do those with low frequency migraines. One practical implication of this research is that Botox is very likely to be as effective for patients with frequent migraines (those with 10-14 headache days a month) as it is for patients with chronic migraines. And indeed, I’ve observed an excellent response in patients with frequent migraines in my almost 20 years of giving Botox injections for headaches. The response for both patients with frequent migraines and chronic migraines is about 70%, which significantly exceeds the efficacy of any prophylactic drug with no potentially serious side effects seen with most drugs.

Art credit: JulieMauskop.com

Getting medicine straight from the nose to the brain

By: Dr. Mauskop

01-06-2013

New treatments

Many migraine sufferers suffer from nausea and vomiting and cannot swallow pills or even if they can swallow them, it takes too long for them to work. Injections is one way to overcome this problem, but nasal spray is a much more pleasant alternative. There are several migraine medications available in a nasal spray form, including Zomig (zolmitriptan), Imitrex (sumatriptan), Migranal (dihydroergotamine), Sprix (ketorolac), and Stadol (butorphanol). Unfortunately, they don’t always work or work inconsistently. Having nasal congestion due to allergies, a cold, or migraine itself often makes these medicines ineffective. Stadol is a narcotic, which can be addictive, while Imitrex and Migranal require delivery into the nose a large volume of fluid, which tends to leak out or gets swallowed, thus reducing their efficacy.

Seattle-based Impel Neuropharma has been working for five years to show it can quickly deliver drugs through the nose, directly to the brain, rather than what happens with the currently available sprays – absorption into the blood stream first and then carried to the brain. Impel, a University of Washington spinoff, recently presented a study of seven patients who used the company’s nose-to-brain drug delivery device, which was able to propel a test protein deep into the upper nasal passages and to the brain stem at an “order of magnitude” greater concentration than a conventional nasal spray. Researchers saw it get delivered to the destination within 10 to 20 minutes. Most nasal sprays don’t propel drugs anywhere close to the upper nasal passages, which is the only place in the body where nerve cells (neurons) are possibly accessible to the outside environment. This device delivers a pressurized, rotational flow of aerosol to reach those neurons.

The company stated that a nose-to-brain delivery device could, in theory, get an effective pain reliever to work more quickly for patients in need of something fast, and do it safely by minimizing the amount that gets absorbed into the bloodstream. It also could be convenient for patients, especially when compared with injectable treatment options.

Art credit: JulieMauskop.com