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8/18/2019 Migraine Package

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DyAnsys MEASUREDyAnsys MEASUREBrought to you by DyAnsys India Pvt. Ltd., For private circulation only April ‘16

When you can measure what you arespeaking about, and express it innumbers, you know something about it;but when you cannot measure it, whenyou cannot express it in numbers, yourknowledge is of a meager andunsatisfactory kind.

- Lord Kelvin (1883)Many qualifications

and long years inpractice have establishedDr. L. Meenakshi Sundaramas one of the leadingmedical professionals in

Chennai, India. He graduated with an M.D.

in General Medicine from Madras Medical

College (one of the premier medicalinstitutions in India). He now has his owcenter for diabetes and internal medicine inRoyapettah, Chennai, India. He has beenpracticing since 1992.This case has been particularly close to hi

heart since it was his wife that was sufferingGreetings!Narcotics are finally

being recognized forwhat they are. Theycause addiction,damage to the brain

and a host of other complications. Areliable, non-narcotic treatment for chronicpain is the need of the hour.

DyAnsys got involved in neurostimulationabout 4 years ago via our ANSiscope. Wefound that chronic pain, almost alwayscauses an imbalance in the AutonomicNervous System, which of course we

measure. It made sense to ally theANSiscope with treatments to provide amonitoring/treatment solution.

Subsequently, we became involved with adevice for auricular neurostimulation calledthe P-Stim. The results achieved wereexcellent. It provided pain relief in amajority of the patients that it was put on.We made a significant commitment to thisbusiness and designed our version of thisdevice called the ANSiStim.

We are now involved in developing thisbusiness, initially in the USA and then inother parts of the world. We expect topublicize successes via this newsletter,

clinical studies, patient testimonials andother marketing activities.This is the first of our Measure issues that is

devoted to one of the diseases associatedwith Chronic Pain – Migraine. We haveknown Dr. Meenakshisunderam for many

years through his diabetology practice. Themain application for the ANSiscope wasdiabetic autonomic neuropathy.

In this issue he talks about treating his wifefor Migraine that had been dogging her forover 15 years. It was completely resistant toany treatment.

Enter the ANSiStim. She is now finallyable to have a majority of pain free days.

More importantly she is able to live anormal life. She expresses her feelings onher own words.

The default treatment for migraines in theUS seems to be Botox. We would hope thatUS physicians would treat their patients first

The patientHis wife (Mrs. M.Meyyammai and 45 years

old) has been suffering from severe migrainefor over 15 years.History

She consulted various top neurologists inChennai without any relief. MRI’s of both thebrain and the heart were done 4 times in the

last 15 years.Initially she also had maxillary sinusitis withfungal balls. The fungal balls were removedthrough endoscopic sinus surgery. Thisrelieved her frontal headache to some extentbut the migraines continued.Various neurologists prescribed rescue

therapy to no avail. Migraine prophylaxistreatment using topiramate, flunarizine,propranolol and others were tried but thepatient did not tolerate these medicines. Sherefused to take these medications since shecould not handle the side effects. In the

meantime she consulted 4 neurologists withoutany result.Management & Outcome

He got to know about the ANSiStim throughrepresentatives of DyAnsys India. He was toldthat this Neurostimulation Therapy wasapplicable to all kinds of chronic painincluding but not limited to arthritis,neuropathy and other chronic painsyndromes.When asked about migraine, he was told

that it has been used on migraine patients inthe US and found to be effective.

The patient was reluctant to try yet anotherform of therapy. He persuaded her to try atleast two to three applications of theANSiStim.The ANSiStim

stimulation by passing minute electriccurrents via the auricular cranial nerves to thbrain.Three points are chosen for stimulatio

depending upon the condition to be treatedThe ANSiStim was mounted behind th

patient’s ear. The three points chosen to treachronic migraine, stimulate

1. The auricular branch of the vagus nerve2. The auriculotemporal nerve3. Greater auricular nerveNote that the auriculotemporal nerve originate

from the mandibular branch of the trigeminnerve. It innervates the anterosuperior ananteromedial aspects of the auricle.

After the second treatment, the patient founthat it relieved her headaches. Remarkablythere were no side effects unlike medicationthat she had been taking.In the meantime she has had “8” treatments

Th it d i t it f th h d h

Alleviation of Migraine in a patientsuffering for 15 years

Lead I : ABVN GAN ATN Lead II : ATN Lead III : ABVN ATN


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DyAnsys™ India Pvt Ltd “MEERLAN TOWERS” 1 st floor No 33 Hanumantha Road Balaji Nagar Royapettah Chennai- 600 0

DiscussionUpon researching this therapy, we found that

the ANSiStim is a patented and FDA clearedminiaturized Neurostimulation device thatoperates on the principle of auricular

Neurostimulation.We are now convinced of the efficacy of thisform of therapy for migraine. More data onthe effectiveness of ANSiStim on this kind ofpatient population will attract the attention ofcontemporary medical practitioners. Theycould recommend as a routine form of therapyto treat migraine.Patient experience

Mrs. Meyyammai wassuffering from Migrainessince 2001 and wasfinding it hard to lead anormal life due to theseverity of pain.“I tried all sorts of

allopathic treatment but was not satisfied byany of them. My husband convinced me to trythe ANSiStim treatment.I saw an improvement in pain after the very

first treatment. In the meantime I have beentreated 8 times. My pain has reduceddrastically.My sleep pattern has improved. I am finally

able to sleep continuously for hours withoutany breaks.Before the ANSiStim treatment my pain level

was a 9. After the ANSiStim treatment mypain level has dropped down to 4.I am now able to pursue my daily activities,

both at home at the hospital, without anydiscomfort. I was able to carry out all my taskseven with the ANSiStim on me.”Referenceshttps://www.botoxchronicmigraine.com/New nerve drugs may finally preventmigraine headaches - David Noonan,Scientific American Health Nov 17, 2015The nerve supply of the human auricle – ElmarT.Peuker & Timm J. Fuller Clin Anatomy 15,35-37DyAnsys application note #44

with the ANSiStim before resorting to moreaggressive treatments.

We are going systematically aboutbuilding this business. You will see moreannouncements, articles, and informationas time goes on.

Unfortunately the default treatment forchronic pain is still narcotics like Oxycontin,Vicodin, morphine and so on.

Major organizations like the AmericanAcademy of Pain Management are nowstrongly advocating the use of lessaggressive treatments before moving on tonarcotics and more aggressive treatments.

Our goal at DyAnsys is to ensure doctorstry the ANSiStim treatments on patientsFIRST before resorting to aggressivetreatments like narcotics.

Faced with an all-time national high of opioid-induced overdoses, the Food anAdministration (FDA) rolled out strict new guidelines for labeling addictive painkilafternoon. These new rules will require fast-acting opioid-based drugs, like OxyContinPercocet, and Vicodin, to come with a new warning about the serious risks of abuse, adoverdose, and deaths linked to the painkiller.These quick-release forms of opioid drugs represent about 90 percent of painkiller pr

the market. And while they are meant to diffuse temporary pain, like a broken bone, wisdremoval, or surgery, these opioids have quickly become the nation’s top drug of choice fostruggling with addiction.“Opioid addiction and overdose have reached epidemic levels over the past decade, an

FDA remains steadfast in our commitment to do our part to help reverse the devastatingthe misuse and abuse of prescription opioids,” said Robert Califf, FDA commissioner, release. Califf said the new regulations are just a part of the FDA’s “comprehensive actto attack the crisis in 2016.This sweeping update is just one of the new ways federal organizations and Congr

expressing their interest in reversing drug addiction. The FDA’s announcement comes a the Centers for Disease Control and Prevention (CDC) released new voluntary guidesuggest primary care physicians limit the dosage of opioid painkillers for patients —alternative treatments for chronic pain before prescribing. Days before, the U.S. Senapassed a bipartisan bill that would fund addiction prevention and recovery programs.The new FDA labels will also include the dangers of using these types of drugs while

Over the past decade, more than 130,000 newborns have entered the world addicted to and facing a painful withdrawal process. Regardless, many pregnant women havprescribed opioid painkillers.But will updating the warning labels on addictive drugs be enough? Some legislators d

think so.Shortly after the FDA’s announcement, Senator Ed Markey (D-MA) told the New York

the changes “have done little to prevent prescription drug opioid addiction,” and that “it the F.D.A. far too long to address the grave risks of these drugs that have claimed thethousands this year alone.”This action failed to address a petition signed by 41 city and state health department h

February, which asked for labeling that warned users of the risk of mixing a painkiller wtype of drug. In its press release, the FDA said it is currently reviewing this risk.

With Opioid Addiction OnThe Rise, FDA Issues New Guideline

For Labeling PainkillersBY ALEX ZIELINSKI MAR 22, 2016 3:09 PM

OxyContin pills at a pharmacy in Montpelier, Vt.


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APPLICATION NOTE

Date: Feb 22 nd 2 16 No. IN 0044

ANSiStim ® & Migraine

Current Treatment

BOTOX® is currently used as a preventive medicine if patients have chronicmigraine i.e. >15 headache days a month. The FDA has approved BOTOXtreatments once every 90 days.

Interestingly, BOTOX prevents up to 9 headache days a month comparedto up to 7 days a month for a placebo injection!

It is injected into 7 key areas of the head and neck at a recommendeddosage of 155 units per treatment session.

BOTOX has side effects that can be serious1. Problems swallowing, speaking or breathing2. Spread of toxin effects causing problems in other areas of the body

i.

Loss of strength and overall muscle weaknessii. Double or blurred visioniii. Hoarseness or change or loss of voiceiv. Loss of bladder control

Recent Insights

Recent developments have identified the trigeminal nerve as the most likelysource of these migraines. (See review article attached).

Migraine has been treated with various methodologies1. Forehead and eyelid surgery to decompress branches of the trigeminal

nerve system2. As well as transcranial magnetic stimulation (TMS - a noninvasive

technique to alter nerve cell activity).TMS has shown some good results.

TMS actually induces currents in areas of the brain causing cranialelectrostimulation.


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APPLICATION NOTE

Date: Feb 22 nd 2 16 No. IN 0044

ANSiStim ® & Migraine

The ANSiStim

The ANSiStim performs cranial electro stimulation by passing minuteelectrical currents via the auricular cranial nerves to the brain.

Three points are chosen for stimulation depending upon the condition to betreated

The three points chosen to treat chronic migraine, stimulate1. The auricular branch of the vagus nerve2. The auriculotemporal nerve

Note that the auriculotemporal nerve originates from the mandibularbranch of the trigeminal nerve. It innervates the anterosuperior andanteromedial aspects of the auricle.

Recommendation

1. Try a sequence of ANSiStim treatments on migraine patients. There shouldbe no side effects.2. The ANSiStim should work for most patients. For those patients who don’t

respond to ANSiStim treatment, one can continue with more aggressivetreatment options.

References

1. https://www.botoxchronicmigraine.com/2. New nerve drugs may finally prevent migraine headaches – David

Noonan – Scientific American Health – Nov 17, 20153. The nerve supply of the human auricle – Elmar T.Peuker & Timm J. Fuller

Clin Anatomy 15, 35-37


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New Nerve Drugs MayFinally Prevent MigraineHeadachesThe cause of migraine headaches has eluded scientists for centuries.Now a theory blaming one nerve has led to drugs that prevent attacksBy David Noonan | Nov 17, 2015

Julia Yellow The 63-year-old chief executive couldn't do his job. He had been crippled by migraine headaches throughout his adultlife and was in the middle of a new string of attacks. “I have but a little moment in the morning in which I can either


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read, write or think,” he wrote to a friend. After that, he hadto shut himself up in a dark room until night. So PresidentThomas Jefferson, in the early spring of 1807, during hissecond term in office, was incapacitated every afternoon bythe most common neurological disability in the world.The co-author of the Declaration of Independence never vanquished what he called his “periodical head-ach,”although his attacks appear to have lessened after 1808. Twocenturies later 36 million American migraine sufferersgrapple with the pain the president felt. Like Jefferson, whooften treated himself with a concoction brewed from tree bark that contained quinine, they try different therapies,

ranging from heart drugs to yoga to herbal remedies. Theirquest goes on because modern medicine, repeatedly baffledin attempts to find the cause of migraine, has struggled toprovide reliable relief.Now a new chapter in the long and often curious history ofmigraine is being written. Neurologists believe they haveidentified a hypersensitive nerve system that triggers thepain and are in the final stages of testing medicines thatsoothe its overly active cells. These are the first ever drugsspecifically designed to prevent the crippling headaches before they start, and they could be approved by the U.S.Food and Drug Administration next year. If they deliver onthe promise they have shown in studies conducted so far, which have involved around 1,300 patients, millions ofheadaches may never happen.“It completely changes the paradigm of how we treatmigraine,” says David Dodick, a neurologist at the Mayo

Clinic's campus in Arizona and president of the InternationalHeadache Society. Whereas there are migraine-specific drugsthat do a good job stopping attacks after they start, the holygrail for both patients and doctors has been prevention.Migraine attacks, which affect almost 730 million people worldwide, typically last from four to 72 hours. Most


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sufferers have sporadic migraines and are laid low during 14or fewer days a month. Those with a chronic form—almost 8percent of the migraine population—suffer 15 or moremonthly “headache days.” Attacks are often preceded byfatigue, mood changes, nausea and other symptoms. About30 percent of migraine patients experience visualdisturbances, called auras, before headaches hit. The totaleconomic burden of migraine in the U.S., including directmedical costs and indirect costs such as lost workdays, isestimated at $17 billion annually.In the 5,000 years since migraine symptoms were firstdescribed in Babylonian documents, treatments have

reflected both our evolving grasp and our almost comicalignorance of the condition. Bloodletting, trepanation andcauterization of the shaved scalp with a red-hot iron bar werecommon treatments during the Greco-Roman period. Thenadir of misguided remedies was probably reached in the10th century a.d., when the otherwise discerningophthalmologist Ali ibn Isa recommended binding a deadmole to the head. In the 19th century medical electricity had become all the rage, and migraine patients were routinely jolted with a variety of inventions, including thehydroelectric bath, which was basically an electrified tub of water.By the early 20th century clinicians turned their attention tothe role of the blood vessels, inspired in part by observationsof strong pulsing of the temporal arteries in migrainepatients, as well as patients' descriptions of throbbing painand the relief they got from compression of the carotid

arteries. For decades to come, migraine pain would be blamed primarily on the dilation of blood vessels(vasodilation) in the brain.That idea was reinforced in the late 1930s with thepublication of a paper on the use of ergotamine tartrate, analkaloid that was known to constrict blood vessels. Despite


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an array of side effects, among them vomiting and drugdependence, it did stop attacks in a number of patients.But if vasodilation was part of the puzzle, it was not the onlything going on in the brains of migraine sufferers, as the next wave of treatments suggested. In the 1970s cardiac patients who also had migraines started telling their doctors that the beta blockers they were taking to slow rapid heartbeats alsoreduced the frequency of their attacks. Migraine suffererstaking medicines for epilepsy and depression, and othersreceiving cosmetic Botox injections, also reported relief. Soheadache specialists began prescribing these “borrowed”drugs for migraines. Five of the medications eventually were

approved by the FDA for the condition. Unfortunately, it isstill not known exactly how the adopted drugs (which areeffective in only about 45 percent of cases and come with anarray of side effects) help migraines. Dodick says they mayact at various levels of the brain and brain stem to reduceexcitability of the cortex and pain-transmission pathways.SEE ALSO: • Mind: Using Pigeons to Diagnosis

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The first migraine-specific drugs, the triptans, wereintroduced in the 1990s. Richard Lipton, director of theMontefiore Headache Center in New York City, says triptans were developed in response to the older idea that the dilationof blood vessels is the primary cause of migraine; triptans

were supposed to inhibit it. Ironically, subsequent drugstudies show that they actually disrupt the transmission ofpain signals in the brain and that constricting blood vesselsis not essential. “But they work anyway,” Lipton says. Asurvey of 133 detailed triptan studies found that they relievedheadache within two hours in 42 to 76 percent of patients.


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People take them to stop attacks after they start, and theyhave become a reliable frontline treatment for millions. What triptans cannot do—and what Peter Goadsby, directorof the Headache Center at the University of California, SanFrancisco, has dreamed about doing for more than 30 years—is prevent migraine attacks from happening in thefirst place. In the 1980s, in pursuit of this goal, Goadsbyfocused on the trigeminal nerve system, long known to be the brain's primary pain pathway. It was there, he suspected,that migraine did its dirty work. Studies in animals indicatedthat in branches of the nerve that exit from the back of the brain and wrap around various parts of the face and head,

overactive cells would respond to typically benign lights,sounds and smells by releasing chemicals that transmit painsignals and cause migraine. The heightened sensitivity ofthese cells may be inherited; 80 percent of migraine sufferershave a family history of the disorder.Goadsby co-authored his first paper on the subject in 1988,and other researchers, including Dodick, joined the effort.Their goal was to find a way to block the pain signals. One ofthe chemicals found in high levels in the blood of peopleexperiencing migraine is calcitonin gene-related peptide(CGRP), a neurotransmitter that is released from one nervecell and activates the next one in a nerve tract during anattack. Zeroing in on CGRP and interfering with it was hard.It was difficult to find a molecule that worked on thatneurotransmitter and left other essential chemicals alone. As biotech engineers' ability to control and design proteinsimproved, several pharmaceutical companies developed

migraine-fighting monoclonal antibodies. These designerproteins bind tightly to CGRP molecules or their receptorson trigeminal nerve cells, preventing cell activation. The newdrugs are “like precision-guided missiles,” Dodick says.“They go straight to their targets.”It is that specificity, and the fact that scientists actually know


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ABOUT THE AUTHOR(S)David Noonan is a science and medical writer. He wroteabout treatments for vertigo in the August issue.This article was originally published with the title "A Pain in the

Brain."


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The Nerve Supply of the Human AuricleELMAR T. PEUKER * AND TIMM J. FILLER

Clinical Anatomy Division, Institute of Anatomy, Westfalian Wilhelms-University, Muenster, Germany

Knowledge of the innervation of the outer ear is crucial for surgery in this region. The aimof this study was to describe the system of the auricular nerve supply. On 14 ears of sevencadavers the complete course of the nerve supply was exposed and categorized. A hetero-geneous distribution of two cranial branchial nerves and two somatic cervical nerves wasfound. At the lateral as well as the medial surface the great auricular nerve prevails. No regionwith triple innervation was found. Clin. Anat. 15:35–37, 2002. © 2002 Wiley-Liss, Inc.

Key words: innervation; external ear; cadaveric study; variation

INTRODUCTION

A detailed knowledge on vascularization and inner-vation of the outer ear is crucial for reconstructive andplastic surgery in this region. Moreover, the innerva-tion of the auricle is the theoretical basis of differentreex therapies (e.g., ear acupuncture). However, dataon the innervation as provided by scientic publica-tions are scarce, incomplete, and inconsistent. Theaim of this study is to describe the system of theauricular nerve supply.

MATERIALS AND METHODS

On 14 ears of seven cadavers the complete courseof nerve supply was exposed under magnifyingglasses. Each branch was dened by identifying itsorigin. The bodies (both sexes, age between 68 and 84years) donated to the Institute of Anatomy had beenembalmed with a mixture of formaldehyde, chloralhydrate, and sorbitum solution. Ramications werecoated with a water-soluble dye and photographicallydocumented. The results were transferred to ascheme of the external ear and classied.

RESULTS

A heterogeneous distribution of cranial branchialnerves and somatic cervical nerves was found.

At the lateral surface the GAN (great auricularnerve) prevails. In 73% of cases the ABVN (auricularbranch of vagus nerve) and in 18% the GAN wasfound on the antihelix solely, and 9% showed a double

innervation. The lobule and the antitragus were sup-plied by the GAN in all cases. The tragus was inner-vated by GAN in 45% solely, in 9% by the ATN(auriculotemporal nerve), and in all other cases byboth of them. The tail of helix and the scapha werealways supplied by the GAN, the spine of helix in91% by the ATN (9% GAN). The ATN was found in80% at the crus helicis; in 20% the ABVN branched onthis part. In 9% the ABVN provided ramication forthe crura antihelices (91% GAN), in 45% of the spec-

imen for the cavity of conchae, and in 100% for thecymba conchae. In 55% two nerves were found on thecavity of conchae (GAN and ABVN). No region withtriple innervation was found. For an overview seeTable 1 and Figure 1A.

At the medial surface of the auricle the LON (less-er occipital nerve) participated in 55% of the innerva-tion of the upper third (in 37% solely). The GANparticipated in 63% (in 27% solely); in 36% doubleinnervation was found. The supply of the middle thirdwas provided in 64% by the GAN (18% solely), in 73%by the ABVN (27% solely), and in 18% by the LON

(in no case solely). Double innervation was seen in55% of the middle third. At the lower third, in 91% of the cases GAN was found (73% solely), and in 27%the ABVN (9% solely). No region with triple innerva-tion was found at the medial surface of the auricle as

*Correspondence to: Dr. Elmar T. Peuker, Institute of Anatomy,Vesaliusweg 2-4, D-48149 Muenster, Germany.E-mail: [email protected]

Received 16 August 2000; Revised 19 January 2001

Clinical Anatomy 15:35–37 (2002)

© 2002 Wiley-Liss, Inc.DOI 10.1002/ca.1089


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well. For details on double innervation see Figures 1Band 2.

DISCUSSION

The external ear appears only in mammals. Thedensity of nerve bers in the human auricle comparedto other regions of the head seems rather high. Inaddition, four different nerves are distributed to theexternal ear. They are partly branchiogenic and so-matogenic. Concerning the sensory innervation, thereis a gap in the origin between the rst and thirdbranchiogenic nerves on the upper side and on the

TABLE 1. Overview of the Innervation Patternof the Lateral Surface of the Auricle

ABVN GAN ATN

Crus of helix 20% 80%Spine of helix 9% 91%Tail of helix 100%

Scapha 100%Crura of anthelix 9% 91%Antihelix 73% 9% 18%Antitragus 100%Tragus 45% 46% 9%Cymba conchae 100%Cavity of concha 45% 55%Lobule of auricle 100%

ABVN auricle branch of the vagus nerve; GAN great auricular nerve; ATN auriculotemporal nerve.

Fig. 1. Scheme of left auricle, lateral aspect.

Fig. 2. A. Lateral surface of the external ear with correspondingscheme. ABVN auricular branch of vagus nerve; GAN greatauricular nerve; ATN auriculotemporal nerve; STA supercialtemporal artery. B. Medial surface of the external ear with correspond-ing scheme. ABVN auricular branch of vagus nerve; LON lesseroccipital nerve; V vessels.

36 Peuker and Filler


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