For Migraine or Cluster headaches, Neurotech is a New Frontier
We’ve all experienced a headache once in awhile but for those who are diagnosed with migraine or cluster headache disorders just one episode can take you out for hours or even days. Make no mistake, migraine and cluster headaches have been recognized as neurological conditions with extremely incapacitating symptoms. Medications are the “tradition” course of treatment but there are new options available. The array of neurotech devices opens a door of opportunities for people living with migraine and cluster headaches.
Migraines are a recurrent throbbing headache typically accompanied by visual disturbances, nausea, vomiting, dizziness, extreme sensitivity to sensory inputs or numbness. About 25% of migraine sufferers experience visual disturbances called an aura. The treatment options are wide ranging from prescription pharmaceuticals such as triptans, over-the-counter medications, injections, chiropractic treatment or acupuncture, but there is still an unmet need.
According to the Migraine Research Foundation, the prevalence of migraine is profound affecting 39 million men, women and children in the U.S. and nearly 1 billion worldwide; making it the 3rd most prevalent illness in the world. Women are about three times more prone to the condition than men. The condition tends to be hereditary with 90% of migraine sufferers having a family history of the condition. People living with the condition experience disabling attacks which can be as short as 2 hours or sustain as long as 72 hours. This has an impact on public health both socially and economically. In 2015, Americans spent over $41 billion on treating migraine headaches while their employers lost more than 157 million workdays.
Cluster headaches are less common than migraines impacting approximately 2 in 1,000 people in the U.S. However, they are deemed far more painful. Known as one of the most painful conditions, cluster headaches tend to occur in bouts or clusters. During a cluster cycle, one may experience an attack 1 to 8 times per day. Episodes typically occur over a period of weeks or months until going into remission. The troubling fact is the onset of cluster headaches typically surface in people aged 20 to 40 years. Unlike migraines, this condition is more prevalent among men than women. Getting a proper diagnosis is a key gateway to proper treatment. In fact, those living with cluster headaches are commonly misdiagnosed as migraine.
There are a variety of conventional treatments and prevention pathways such as medications or injections. Alternative therapies could also be feasible such as acupuncture and even homeopathic herbs and supplements. In the last few years there as been an array of research and new device offerings for the treatment of migraines and cluster headaches. Depicting this indication as a growing area of neurotechnology.
Available devices
Neurotechnology devices have been slowly emerging from research laboratories to commercial availability. There’s an array of neuromodulation modalities that are highlighted here.
Vagus Nerve Stimulation
The vagus nerve, known as the 10th cranial nerve, is the longest of the cranial nerves running from the brain to the abdomen. It is a complex bundle of nerves and part of the parasympathetic nervous system. ElectroCore Medical offers a non-invasive vagus nerve stimulation treatment for both the prevention and acute treatment of migraine and cluster headaches. The gammaCore device is CE mark approved as well as approved in Canada and the U.S. In 2016, the company gained positive guidance from the U.K. National Institute of Health and Care Excellence (NICE) for reimbursement.
Trigeminal Nerve Stimulation
Taking the form of a surface neuromodulation device, TNS is approved in Europe, Canada, and the U.S. The Cefaly device by STX-Med out of Belgium has been available for several years. Looking more like something from the Star Trek era, this small, non-invasive device delivers electrical stimulation to the trigeminal nerve while placed on the forehead. In a 67-person clinical study, results showed that those using the Cefaly device experienced fewer days with migraines per month and used less migraine attack medications. In a patient satisfaction study consisting of 2,313 users across France and Belgium, more than 53 percent were satisfied with the device and were willing to buy it. The device retails for $379USD and can be purchased with a prescription. They sell directly in the U.S., Belgium, France and Germany. Outside of these markets, they are working exclusively with country distributors.
Earlier this year, Neurolief received FDA clearance for their non-invasive, dual stimulation device for the treatment of migraine headache. The Relivion device is worn on the head over the lower forehead delivering stimulation to both the trigeminal nerve and the occipital nerve. The regulatory clearance is based on a multi-center, prospective, double-blind, randomized placebo-controlled clinical trial. This study involved 131 participants and demonstrated that 46% of those receiving treatment were able to achieve complete pain freedom. Plus, pain relief was experienced within 2 hours of treatment for 60% of the treatment group. Relivion is also available in Israel.
Peripheral Surface Stimulation
Another new entrant to the surface stimulation migraine treatment arena is Theranica Bio-Electronics. Their Nerivio Migra device is an electrical nerve stimulation device worn as an arm band with surface patch electrodes containing a low-powered battery and a smart chip. The device uses electrical stimulation to block pain signals and is controlled through a smartphone app that communicates via Bluetooth. In a study that included 71 people living with episodic migraine, the participants were asked to begin treatment after the start of a migraine and use it for 20 minutes without taking any medications for two hours. Sixty-four percent of the people had a reduction in pain by at least 50 percent two hours post migraine. Researchers also found that initiating the stimulation within 20 minutes of the onset of a migraine was more effective. The device is available in Europe, U.S. and Israel.
Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) is a modality in the form of a wearable brain stimulator. It delivers low electrical current to the scalp and applies a positive and negative current through electrodes. It is believed to alter neuron firing in order to augment synaptic plasticity of the brain. It is often used in combination with training to improve retention, such as motor rehabilitation. Soterix Medical offers their non-invasive PainX device for the treatment of migraine headache in select countries, including Australia, Brazil, Canada, Signapore and the EU. This neuromodulation therapy is delivered as a prevention tool that is administered in a doctor’s office. The in-office treatments take around 30-minutes and require 2–5 visits per week until maximum benefit is realized. This may take several weeks but after then periodic visits are only needed as maintenance sessions.
Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) commonly used for the treatment of depression and chronic pain. For migraine headaches, TMS works by creating a focused magnetic pulse that passes non-invasively through the skull, inducing an electric current. The technology sends signals to disrupt the abnormal brain waves known as cortical spreading depression; a condition that precedes migraine with aura. Some studies have also suggested that CSD may be present in migraine without aura. By disrupting CSD early, TMS treatment may preempt a headache altogether, reduce the duration or severity of a migraine episode, or reduce the frequency of migraine attacks. eNeura Therapeutics (formerly Neurolieve) gained FDA and CE mark approval for their hand-held device, sTMS mini. At this time, the device is no longer available regardless of the safety and efficacy data.
Devices under investigation in Clinical Trials
Even with several neurotech devices on the market, the pipeline of device development is attracting a crowd as well with on-going clinical trials.
Deep brain stimulation involves a surgical brain implant and has been applied for people with tremors from Parkinson’s disease, dystonia and essential tremor. DBS has been investigated for migraine and cluster headache but with the high surgical risk and a few adverse events, it is not gaining much traction as a treatment option.
Another existing therapy used to treat anxiety and insomnia is current under investigation for the treatment of migraine headache. Transcranial Alternative Current Stimulation is a modality similar to tDCS but instead of a direct current stimulation, tACS delivers alternating current stimulation. The effectiveness of this therapy for the treatment of migraine or cluster headache is still unknown. The most recent clinical trials have been completed, but the results have yet to be published. The sponsor of these trials was Fisher Wallace.
A novel implantable technology is being developed by an early stage company based in the Netherlands, Salvia Bioelectronics. Their minimally invasive device stimulates both the trigeminal and occipital nerves. The conforming bioeletronic foil technology is designed to adapt to the anatomy of the person using the device. The company is targeting people living with refractory migraines, those who do not respond to currently available treatments. There are no open clinical trials that are actively recruiting at this time. After receiving FDA Breakthrough status in 2020, this is a company to watch.
Sphenopalatine ganglion (SPG) stimulation is another implantable device targeting people living with cluster headaches. The company, Unity HA, also recently received FDA Breakthrough status. The Pulsante Microstimulator System delivers on-demand stimulation of the SPG, which plays a critical role in cluster headache. The device is activated using an external remote controller, giving the user the ability to administer as-needed stimulation to relieve the attack. Unity HA recently acquired the technology from ATI. The current status of their clinical trials is unknown. Along with this new acquisition comes hope that a new treatment is forthcoming.
One other start-up company based in Minneapolis, MN and Ireland, Shirtronics, is targeting the treatment of migraine headache. Little is know about this company but the device is anticipated to be a surgical implant. There are currently no active clinical trials but the company is raising funds from some key investors in the neuromodulation industry. This is one potential therapy. Still, curb your enthusiasm until there is more information and clinical data.
The variety of neurotechnology devices that are currently available offers a variety of non-pharmacological options for people seeking treatment for their migraine or cluster headaches. Even more so, the array of modalities under investigation could expand these options even more.
Resources
More information about the devices mentioned in this feature are available in the free directory on the Neurotech Network Migraine & Cluster Headache Information page. You will find a listing of the devices mentioned here, links to device sites and more. The content for this article was provided by Neurotech Network.
Special thanks to the following organizations for references to this feature: American Migraine Foundation, Migraine Research Foundation, The Migraine Trust, ClusterBusters
