We use a neuronavigation system from Soterix (on the left) for precise targeting of transcranial magnetic stimulation (TMS). And we use the most advanced TMS machine from MagVenture (on the right) to treat chronic pain, migraines, fibromyalgia, and other neurological conditions.
neurostimulation
Medication overuse or rebound headaches can occur as the result of excessive intake of caffeine, opioid analgesics, and short-acting barbiturate drug, butalbital (contained in Fioricet, Esgic and similar drugs). These three substances not only worsen migraine headaches, they are also addictive. Two of my patients with medication overuse headaches were able to stop the offending drugs with the help of repetitive transcranial magnetic stimulation (rTMS).
One patient, a 51-year-old man, had his migraines under control with Botox and infusions of eptinezumab (Vyepti) until he sustained a head injury with a skull fracture. His migraines worsened and he became disabled. A variety of therapies failed to reduce his pain. His pain was partially relieved by 60 mg of oxycodone a day, although he still was unable to work. After six weekly sessions of rTMS he was able to start reducing his oxycodone intake and after eight, he completely stopped it. He was able to return to work with the help of injections of fremanezumab (Ajovy).
Another patient, a 50-year-old woman, had been taking butalbital with caffeine and acetaminophen (Fioricet) for 20 years. The number of pills increased over time and for the previous several years, she had been taking 10 to 12 tablets every day. She was also receiving Botox injections, infusions of eptinezumab, and taking rizatriptan (Maxalt), 10 mg three times a day as well as 60 mg of nortriptyline, 12 mg of tizanidine nightly and atogepant, 60 mg. She had tried a wide variety of other treatments but was unable to reduce her Fioricet intake. Despite her persistent migraines, she was able to take care of her family. After three weekly sessions of rTMS she reduced her Fioricet intake to 3-4 a day, by the third month she was taking one a day, and after 6 months she was completely off it. She was also able to stop atogepant and tizanidine and reduced her nortriptyline to 25 mg.
In addition to helping relieve pain and migraines, rTMS has shown promise in the treatment of addiction, particularly in addressing withdrawal symptoms, depression, and cravings. While the use of rTMS for addiction is still relatively recent and not yet FDA-approved, some studies have demonstrated positive outcomes. For instance, a double-blind study showed that individuals receiving rTMS therapy for cocaine addiction had a higher rate of abstinence compared to those who received standard treatment. rTMS for addiction is still considered experimental, and more research is needed to fully understand its long-term effects and optimal treatment parameters.
Read MoreNeurologists frequently find themselves managing patients resistant to standard treatments due to limited proven therapies for many neurological conditions. Some patients cannot tolerate or have contraindications to medications, particularly for such common disabling conditions like migraine and chronic pain.
One promising treatment is transcranial magnetic stimulation (TMS). It is a proven procedure for anxiety, depression, obsessive-compulsive disorder (OCD), smoking cessation, and acute migraines. TMS utilizes magnetic fields to stimulate nerve cells in the brain that are underactive or reduce the excitability of overactive cells. TMS can change the flow of information between different parts of the brain in various neurological conditions. Published reports show the potential benefit of TMS in fibromyalgia, neuropathic pain, cluster headaches, facial pain, trigeminal and other neuralgias, back pain, insomnia, memory disorders, tinnitus, post-concussion syndrome, post-traumatic stress disorder (PTSD), restless leg syndrome, and long COVID. The evidence for the efficacy of TMS for these neurological disorders, however, is still limited.
Single-pulse TMS is approved by the FDA for the acute treatment of migraines with aura. The patient uses a portable device during the aura phase to self-administer a single pulse of TMS to the back of the head. This can abort the attack. Repetitive TMS (rTMS) has been studied for the prevention of migraines and other types of pain. It appears effective, but compared to depression trials, migraine studies were relatively small and the FDA has not cleared rTMS for the treatment of migraines. This means that insurance companies are not likely to pay for this “off-label” use of TMS.
rTMS is generally considered safe and well-tolerated, with side effects typically mild and temporary, including scalp discomfort, headaches, and facial twitching. More serious side effects like seizures and mania are very rare.
Before starting TMS, patients undergo a physical and mental health evaluation. The coil placement and dose are determined in the first session. During a TMS session, patients sit in a comfortable chair with earplugs. An electromagnetic coil is positioned near the scalp, delivering short magnetic pulses to specific brain regions involved in processing pain and other information. Patients feel and hear rapid tapping on their scalp that continues, on and off. Patients are awake and alert during the entire procedure. There are no limitations to activities before or after the treatment.
Treatment length varies from 20 to 45 minutes, depending on the stimulation pattern and number of sites stimulated. The frequency of treatments also varies – anywhere from daily for several weeks, to once a week. After the initial period of more frequent sessions, some patients require weekly or monthly sessions to maintain the effect. It may take a few weeks to see noticeable effects.
TMS is a good choice for people who have not responded to multiple standard therapies, people who do not want to take drugs, those who also suffer from depression and anxiety, and pregnant women. Sufficient evidence suggests that TMS is as safe in children as it is in adults, with studies indicating its effectiveness in treating depression in adolescents.
Read MoreMost people are right in not wanting to take medications. They can have serious or just very bothersome side effects, they help only some people and can be expensive. Fortunately, there are many ways to control migraines without drugs. Here are the top 10 non-drug therapies for migraine headaches among several dozen described in my book, The End of Migraines: 150 Ways to Stop Your Pain.
Non-drug therapies
- Aerobic exercise
- Meditation
- Magnesium
- CoQ10
- Cognitive-behavioral therapy
- Acupuncture
- Nerivio
- Cefaly
- Riboflavin
- Boswellia
Magnetic stimulation with a single pulse has been shown to be effective in aborting a migraine attack with the eNeura Spring TMS device.
Repetitive magnetic stimulation (rTMS) of the brain has been shown to relieve depression. A pilot study just published in the journal Brain Stimulation examined the effectiveness of repetitive magnetic brain stimulation for the prevention of migraine attacks.
German and Moldovan researchers conducted a double-blind, randomized controlled study in patients with episodic migraine. They compared real and sham stimulation in 60 patients. Participants received six treatment sessions over two weeks. The primary outcome measure was the number of patients whose migraine days dropped by 50% or more. The frequency and intensity of migraine attacks over a 12-week period were also assessed.
Real rTMS produced at least a 50% reduction in migraine days in 42%. This number was 26% in the sham group. The mean migraine days per month decreased from 7.6 to 4.3 days in the real rTMS group and from 6.2 to 4.3 days in the sham rTMS group. The reduction in migraine attack frequency was also higher in the real rTMS compared to the sham group. No serious adverse events were observed.
There are a couple of practical issues with this treatment approach. The rTMS equipment is already being used for depression, which in theory should make it easy to adapt for migraines. However, this treatment is time-consuming and expensive and is not likely to be covered by insurance. Another problem, which we also encountered in our study of transcranial direct current stimulation, is that there are many variables to consider. Placement of electrodes, the strength of stimulation, frequency, and duration of treatments are some of these variables.
Read MoreThe pain of cluster headaches is considered to be the worst of all headaches. Hence the moniker, suicide headaches. Thankfully, it is a rare condition. Episodic cluster headaches affect a little over 0.1% of the population or approximately 400,000 Americans. Of these, about 15% suffer from chronic cluster headaches. The division of cluster headaches into chronic and episodic is arbitrary, just like it is with migraines. Cluster headache attacks occurring for one year or longer without remission, or with remission periods lasting less than 3 months are considered to be chronic. Patients often go from episodic into chronic and back into episodic.
The term cluster comes from the fact that headaches occur daily or several times a day for a few weeks or months and then stop for a year or so. The attacks are always one-sided and the pain is localized around the eye. It can be associated with tearing, droopy eyelid, and nasal congestion on the side of pain. Some patients also have redness of the eye, sweating of the face, and tenderness in the back of the head.
These headaches are often misdiagnosed as migraine or sinus headaches. It can take several years before a patient receives the correct diagnosis and appropriate treatment.
The only FDA-approved preventive treatment is monthly injections of galcanezumab (Emgality). It came Verapamil, a calcium channel blocker used for hypertension, is another very effective drug. The dose of verapamil for cluster headaches is much higher than for hypertension – up to 960 mg a day. The only FDA-approved treatment for the treatment of individual attacks is sumatriptan (Imitrex) injections. Inhalation of pure oxygen through a mask at high flow (10-12 liters per minute) helps abort attacks in about 60% of patients. A course of steroids, such as prednisone, can sometimes stop the cluster period. These treatments are less effective for chronic cluster headaches.
Another treatment that can stop cluster attacks is an occipital nerve block. It is usually done with a steroid drug and a local anesthetic. The efficacy of this treatment led researchers to try electrical stimulation of the occipital nerve (ONS). It has been also tried in chronic migraines with mixed results.
Conducting trials of electrical stimulation presents big challenges. It requires surgical implantation of the stimulating wire next to the occipital nerve and the battery-operated device under the skin. It is impossible to disguise the sensation patients get from the electric current. They need to feel the stimulation in order for it to be effective.
A study just published in the journal Lancet compared strong and weak stimulation. The authors, led by Leopoldine Wilbrink, deserve great credit for conducting this difficult study. Despite the rarity of chronic cluster headaches, they were able to enroll 150 patients over a period of seven years. After a 12-week baseline observation, the patients were treated for 24 weeks.
The results showed that both weak and strong stimulation were equally effective. About half of the patients in each group had a 50% decrease in attack frequency. The most common side effects were local pain, impaired wound healing, neck stiffness, and hardware damage.
Another study by French researchers, Long-Term Efficacy of Occipital Nerve Stimulation for Medically Intractable Cluster Headache, was published last year in Neurosurgery. The mean duration of treatment observation was 44 months. Attack frequency was reduced by more than 50% in 69% of patients. Mean weekly attack frequency decreased from 22.5 at baseline to 10 after ONS. Functional impact, anxiety, and quality of life significantly improved after ONS. In excellent responders (59% of the patients), attack frequency decreased by 80% and quality of life dramatically improved from 38/100 to 73/100. 67 patients experienced at least one complication, 29 requiring an additional surgery: infection (6%), lead migration (12%) or lead fracture (4.5%), hardware dysfunction (8.2%), and local pain (20%).
ONS is a relatively safe treatment option for patients with chronic cluster headaches who do not respond to standard therapies. It is certainly safer than deep brain stimulation that has been reported to help some patients. Before resorting to ONS, I would also first try Botox injections, which I find to be effective in about a third of patients.
Besides ONS, vagus nerve stimulation (VNS) deserves further study. Two of my patients with severe chronic cluster headaches responded well to implanted VNS. This report led researchers to develop a non-invasive device to stimulate the vagus nerve. It was shown to be effective for episodic but not chronic cluster headaches. In my experience, however, it is only modestly effective even in episodic cluster headaches and is prohibitively expensive. The implanted VNS provides continuous stimulation. The non-invasive VNS is applied for only two minutes at a time. Future studies could compare the efficacy of ONS and implantable VNS.
Read More
My new book, The End of Migraines: 150 Ways to Stop Your Pain, was just published by Amazon. It is also available on Google Play and Kobo.
I am very grateful to all my colleagues who took the time to read the book and to provide advance praise for it.
This is a self-published book. This allows me to update it regularly and to set a very affordable price – the e-book version is only $3.95 and the paperback is $14.95. The e-book version has the advantage of having many hyperlinks to original articles and other resources.
If you read it, please write a brief review on Amazon or Google and spread the word about it.
Cefaly is a neurostimulation device that was approved by the FDA in 2014. Until October of this year, it required a prescription. Several clinical trials proved the device to be not only effective but also very safe. Now it can be purchased without a prescription from the manufacturer’s website – Cefaly.com.
Cefaly is used for both prevention and acute treatment of migraine. It is applied to the middle of the lower forehead with an adhesive electrode. For acute therapy, the device is used for 60 minutes. For prevention, it is used daily for 20 minutes. Some of my patients find it effective on its own while others use it in conjunction with medications.
As far as side effects, the device is very safe. It can cause skin irritation from the adhesive or from the electrical current. Some of my patients reported worsening of their headaches. This tends to happen to patients who develop allodynia during their migraine attack. Allodynia means increased skin sensitivity. It can be so severe that sometimes a patient cannot even wear glasses or have a ponytail.
An electrical stimulation device that is better tolerated by patients with allodynia is Nerivio. It is applied to the upper arm for 45 minutes as needed. Nerivio requires a prescription but it is sometimes covered by insurance while Cefaly is not.
Read MoreIt’s been a year since the introduction of Nerivio, an electrical stimulation device for the acute treatment of migraines. One of the unique features of the device is that it is controlled by a smartphone app. This allows Theranica, the manufacturer of Nerivio, to collect data on its use. They just published real-world data on the use of Nerivio in the first 6 months after its introduction.
59% or 662 out of 1,123 patients treated by headache specialists and 74% or 23 out of 31 patients treated by non-headache specialists reported pain relief at two hours in at least half of their treated attacks. Complete pain freedom was achieved by 20% of the patients in the first group and 36% in the second group in at least half of their treated attacks. Only 0.5% of the patients reported device-related adverse events.
The number of patients treated by non-headache specialists is small. Nevertheless, because headache specialists tend to see patients who are more severely affected by their migraines, it is likely that the device will be more effective in the hands of non-headache specialists, or rather on the arms of patients treated by such doctors. Nerivio is a disposable device that is placed on the upper arm for 45 minutes.
My subjective impression correlates with this published data. Some of my patients use it along with their abortive medications such as triptans or NSAIDs. One patient finds that the stimulation not only relieves pain but is also very relaxing. Even though you can continue your normal activities, I recommend that patients try to relax or meditate during this treatment. The advantage of Nerivio is that is a drug-free treatment and is very safe. People who find Nerivio particularly appealing are those who have side effects from drugs, have multiple allergies, pregnant or nursing, and for whom drugs are ineffective.
Nerivio is available by prescription from your healthcare provider, by consulting (virtually or in-person) one of our headache specialists, or by connecting to a doctor on Cove, a telemedicine startup.
Disclosures: I have provided consulting services to both Theranica and Cove.
Read MoreTo be eligible for this study you have to live in NYC or its suburbs and cannot be currently receiving Botox or a CGRP monoclonal antibody, such as Aimovig, Ajovy or Emgality.
PARTICIPATE IN MIGRAINE RESEARCH
A RANDOMIZED SHAM-CONTROLLED STUDY OF HOME-DELIVERED NON-INVASIVE NEUROSTIMULATION FOR MIGRAINE
• If you have frequent headaches (on 4 days or more/month) you may be eligible to enroll in a study of non-invasive neurostimulation aiming to reduce migraines.
• Neurostimulation provides stimulation of the nerves in the human body. Frequently used neurostimulation methods are for example, acupressure, acupuncture or TENS.
• This study uses a new neurostimulation method, tDCS. tDCS is a battery-powered device that delivers stimulation via two sponge pockets placed to a simple headband. Study participants will be assigned either to a group receiving active tDCS or to a control group receiving placebo tDCS.
If you are interested in more information about the study, please call the study personnel at 212-794-3550 or 212-440-1954 or email DrMauskop@nyheadache.com
Read MoreI’ve given myself an injection of Ajovy in November and December with some improvement and without constipation which I had from Aimovig. However, Ajovy did not prevent all of my migraines, especially those caused by red wine, (I received some nice red wine over the holidays) and I still had to take sumatriptan (Imitrex).
This is not at all surprising; I always tell my patients that even the most effective treatment is not 100% effective – with enough triggers migraine will still occur. It is possible that with continued use of Ajovy my migraines would progressively get better, but my headaches are quickly and completely relieved by sumatriptan. Sumatriptan has a 25 year safety record and for over 10 years has been available without a prescription in most European countries (you may want to read my post on the daily use of triptans – it is by far the most popular with over 250 comments).
My next self-experiment is to try to prevent migraines with transcranial direct current stimulation (tDCS). We are about to begin a double-blind sham-controlled study and I will describe it in in an upcoming post.
Read MoreAn electric stimulation device, gammaCore has received clearance from the U.S. Food and Drug Administration (FDA) as an acute treatment of pain associated with migraine in adult patients. gammaCore is a hand-held device that stimulates the vagus nerve in the neck through the skin and was developed following and based on my 2005 publication describing the use of implantable vagus nerve stimulator for refractory chronic cluster and migraine headaches. This adds to the approval gammaCore received for the acute treatment of pain associated with episodic cluster headache in adult patients in April 2017. The clearance is limited to pain of migraine, rather than migraine attacks, meaning that the device relieves pain and may not relieve other migraine symptoms, such as nausea and sensitivity to light and noise.
The FDA clearance of gammaCore for the acute treatment of pain associated with migraine was supported by the results of the multicenter, randomized, double-blind, sham-controlled trial that demonstrated that “treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with sham treatment”. Just like with all other studies with gammaCore, the therapy was found to be well tolerated by patients.
gammaCore is also available outside of the U.S., including in Canada and the European Economic Area. The manufacturer offers a free trial of the device, which cannot be purchased, but only rented. Some insurance plans may pay for the rental.
Here are a few disclaimers and warnings from the manufacturer:
The safety and effectiveness of gammaCore (non-invasive vagus nerve stimulator) has not been established in the acute treatment of chronic Cluster Headache.
This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
The long-term effects of the chronic use of the device have not been evaluated.
Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for:
Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
Pediatric patients
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Patients should not use gammaCore if they:
Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
Are using another device at the same time (eg, TENS Unit, muscle stimulator) or any portable electronic device (eg, mobile phone)
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