The Migraine Solution of the Future Might be Found in a Few Puffs of Air.
Those of us who suffer from migraines know the drill: when a migraine strikes, life as you know it is different. Even if you can make it to work, brain fog, sensitivities to light and sound make it nearly impossible to carry out the simplest of tasks. So you turn to medication and/or other migraine treatment devices in the desperate search for relief. The insult to injury? These currently available “solutions” are only around 30% effective. The drugs can also often have undesirable side effects; while the devices, which deliver electrical current or energy through the skin, can also be unpleasant or even painful to use.
What if the long awaited answer was simply found in a few puffs of air?
Nocira, LLC is a pre-market medical device company in clinical evaluation of an investigational new migraine treatment device designed around a seemingly simple, yet potentially disruptive, new approach for migraine treatment – a few puffs of air. More specifically, the investigational Nocira therapy delivers a modulated pattern of precisely controlled, gentle puffs of air into the ear – and which is intended to stimulate pressure-activated sensory neurons to reset pain mechanisms in the brain for treating migraines.
Nocira’s Vision for the Future: Patient Relief and Satisfaction From a Drug-Free, Comfortable & Pleasant to Use, Reliable Migraine Therapy.
Of course, this vision represents goals that are shared by many. But in the world of a migraine sufferer, there are essentially two choices today: deal with the pain, or deal with the side effects or other unpleasantries of the current treatment options that fail more often than they succeed for achieving relief.
At Nocira, we believe relief should and can be more reliably and rapidly achieved, and without being burdened by the other issues associated with delivering drugs or electrical/magnetic signals into the body. Consistent with that mission, the investigational Nocira solution is designed to harness the body’s natural sensory response to slight pressures changes in the ear to naturally modulate and reset pain mechanisms in the brain.
Most people prefer to not take drugs for their migraine but until now, there have been few other options available. For many headache sufferers, drugs just don’t work. Nocira’s non-invasive device is being designed and evaluated with the hopes to offer migraine sufferers an appealing alternative in the future.
Published Clinical Pilot Study Results
According to published results from an IRB-approved pilot clinical study evaluating the Nocira therapy for single episode moderate-to-severe migraines in n=30 patients (under informed consent): 67% of the study patients were pain-free in 20 min after Nocira treatment.
In addition, most study patients also reported a favorable and very comfortable experience with the Nocira device and treatment method.
Reference: George, D.M. & Pagnacco, G. & Willey, K.E. & Claude, J.P. & Oggero, E. (2017). Safety and usability factors in development of a novel, automated treatment device for acute migraine. Biomedical sciences instrumentation. 53. 398-403.
NOCIRA IS NOW PREPARING TO CONDUCT A DOUBLE-BLINDED, RANDOMIZED,PLACEBO-CONTROLLED, MULTI-CENTER CLINICAL TRIAL IN ORDER TO MORE FORMALLY EVALUATE THE CLINICAL effectiveness AND SAFETY OF THE PLATFORM IN A WIDER PATIENT POPULATION.
More Than Just a Treatment, Nocira is designed for a Pleasurable Experience
Can a migraine solution actually feel good? Can it also work quickly? Nocira believes the answers to both these questions should be YES and YES – and we have designed and are evaluating our approach with a commitment to achieving these objectives. Our goal is to provide more than just a migraine treatment – but to create a pleasurable and soothing therapeutic experience. Through comfortably seated earpieces, the ear pressure changes are precisely controlled by the device and without any required manipulation by the patient. Much like a massage, this is intended to provide an entirely passive experience for the user: simply turn it on, seat the comfortable earpieces, relax, and let it go to work.
Nocira’s Design Commitment: A “Smart” Solution
We all rely on our smart phone in our daily lives – which is why we designed the investigational Nocira therapy to be controlled via a bluetooth connection with a downloadable mobile device app. Our hope is to provide patients with a simple and familiar way to use the device. An appealing, interactive screen is designed to allow users to input information about their migraines and to also monitor their therapy when it is in progress. The app is also being designed to make the Nocira system adaptable to learn about each patient’s unique landscape and patterns around their migraines, including their response to the Nocira treatments – and which may mean even faster, more effective relief in the future.
Nocira’s Design & How it Works
The investigational Nocira device includes a small pocketable pump connected by a thin tube to comfortable earpieces, similar to in-ear audio earpieces. A Nocira mobile phone app controls the system to deliver precisely controlled air pressure pulses into the external ear canal. The subtle pressure changes are believed to stimulate a uniquely rich population of pressure-activated sensors in the external and middle ear. This, in turn, is believed to stimulate multiple nerves that target the brain’s pain centers to essentially ‘reset’ overactive pain-generating areas back to a calmed, non-painful state.
More specifically, this stimulation is believed to include sensory branches of both the vagal and trigeminal nerves, among other nerves, that have been associated with pain modulation. These multiple sensory nerves all uniquely converge in the ear unlike any other known place in the body. Nocira believes that this targeted stimulation of these parallel mechanisms via the single portal of the ear might provide distinct advantages in the speed and extent of achieving a desired therapeutic effect. This is also in stark contrast versus other recently approved migraine treatment devices that target a single nerve mechanism (e.g. vagal or trigeminal) at other target locations (e.g. specific sites along the neck or head).
What does all that mean? Nocira proposes a novel and potentially disruptive solution that targets the activation of multiple migraine relief mechanisms by simply making small pressure changes in the ear. This may be a true case of “Less is More.”
Nocira’s Design for Precision Control – More than Just a Feature…
Simple as it might first appear to be, the air pressure modulation of the Nocira system is not really just ‘simple’ puffs of air. Nocira has conducted extensive development in the precise control by which the air pressure changes are delivered to the ear. This is intended to enhance the ability to achieve maximum therapeutic effect, yet while also remaining comfortably within the published range limit standards for safe pressure changes in the ear.
There are many medical procedures that have long involved changing pressures within patients’ ears. These include fairly standard and routine diagnostic procedures that use manual “insufflation” devices with baffles or “bulbs” that a medical professional squeezes to change pressure through an earpiece seated in the ear. Nocira has conducted its own internal testing with such standard manual insufflation devices to evaluate the range of pressures they are capable of achieving when manually actuated. These test results revealed that such manual insufflations are capable of over-pressurization up to several times above the standard maximum safe pressure guidelines for the ear. While manual ear insufflation is generally considered safe in the hands of skilled medical professionals trained in safely conducting such procedures, Nocira believes it could pose significant safety risks in the hands of a patient who might try to self-treat their own ears. Hence the high priority that has been placed on requiring precise pressure control in Nocira’s design.
Nocira’s precise pressure control is also fundamental to the investigational therapy itself. The Nocira ‘puffs of air’ are actually delivered as changing pressure “patterns.” This approach is intended to optimize therapeutic effect by varying the sensory stimuli within the ear, and also to reduce the potential for habituation (i.e. a physiologic desensitization to a repetitive stimulus).