The Most Effective FDA Cleared Therapy for the
Prevention of Medically Diagnosed Migraine Pain
NTI Tension Suppression System
       When you wake up...

                                                                       ...do you feel fabulous?

Dr. James P. Boyd, developer of the first medical device to be cleared by the FDA for the prevention of medically diagnosed migraine pain, discusses the most important and most over-looked aspect of the diagnosis of chronic headache and migraine pain.

When you wake up, do you feel fabulous?

Seems like a silly question, doesn't it?  If I had to boil it down to one concept that has made the NTI therapeutic protocol so successful at migraine prevention, is the acknowledgement that most chronic migraine and headache sufferers don't (or won't) admit that upon waking in the morning, having some degree of discomfort above their shoulders is completely "normal" for them.  Not just headache or even full blow migraine...it could be the facial/forehead and back-of-the-neck combination pain, sore and stiff jaw, or "sinus" headache. 

In comparison to the migraine episodes they experience, their "morning headaches" are somehow manageable, and therefore in their mind, not worthy of including in their complaints to their health care provider.  Unfortunately, unless this critical component of their condition is acknowledged and resolved, effective prevention and management of their chronic migraine and headache pain is unlikely.

They've seen plenty of doctors for their headaches.  They're asked specific questions regarding the degree of pain that alters their normal function like, "When do you get your worst headaches...", and "What makes your headache worse?", or "How many times per week/month do you have a migraine?".    Rarely, if ever, is a chronic migraine or headache sufferer asked, "Exactly when DON'T you have any degree of headache, even the slightest?".

The biggest obstacle in successful management and prevention of chronic migraine and headache pain, is the lack of a complete diagnosis.  A diagnosis of a patient's condition is NOT simply a medical label that represents the sufferer's signs and symptoms, that's just HALF of the diagnosis.  Diagnosis is defined as:  "The nature and cause of a disease or injury", where the signs and symptoms represent the nature of the disease, in this case, the description of the nature of the suffers head pain. 

Obviously, the most important half of a complete diagnosis is the cause of the disease.  Many, many diseases have "headache" as one of the symptoms and when the cause of the certain disease is cured or controlled, the headaches resolve.  The diagnosis of "migraine" is unusual, in that a diagnosis of migraine is made after no medical cause can be found.  Medical researchers believe they understand the neurophysiology of migraine pain, but since they cannot isolate a common cause, sufferers are informed that the first order of business of their migraine prevention treatment is to avoid those circumstances that seem to "trigger' their attacks.  NONE of the common triggers for migraine pain have ever been shown to cause pain in a normal person, yet for a migraineur, they can launch a debilitating episode of pain.

Here's an analogy:  Imagine a woman coming home from a hard day at work, where for several days, she's been assigned difficult, stressful tasks. These tasks are not abnormal to her, but their length and intensity are more than "normal".  She does not address or consider the effect they might be having on her.  She comes home and discovers her checking account is overdrawn and the plumbing is backed up.  She enters the kitchen and is asked by her children, "Where's dinner?"  

For any normal person, being asked, "Where's dinner?" would not illicit an intensely stern and aggressive reply.  Only if you understood what she's been going through would you understand why she "snaps" with a stern, aggressive, irritated response.  Her response isn't caused by any abnormal circumstance, but by an excessive degree of normal circumstances. 

So how does this relate to the cause of chronic headache or migraine pain?  Migraine is considered a disorder of the Trigeminal nerve system.  The Trigeminal gets it name from its three sensory divisions that bring information to the brain; from the scalp, the face/sinuses, and jaw.  Neurologists who treat migraine are concerned with the first two divisions, which bring in information (sensations) from the scalp/forehead and sinuses.  The current hypothesis in the cause of chronic migraine is that there must be some kind of negative (or "noxious") information coming in from these two divisions, such that the system becomes fatigued or irritable, thus becoming susceptible to a "trigger" which launches a painful attack along those same sensory nerves.  

By the way, that's the hypothesis of Botox for prevention of chronic migraine.  By injecting Botox into certain nerve endings of the scalp, neck and shoulders that deliver information to the brain, the Botox will reduce the information flow, thereby reducing the sufferer's "triggerability".

But what of the remaining third division of the Trigeminal?  The third division, the mandibular (jaw) has two roles.  Not only does it receive sensory information from everything in your mouth and delivers it to the brain, it carries "motor" information from the brain to the muscles of chewing, and most importantly for our concerns, the large clenching muscles that cover the temples (the temporalis muscles). 

Now consider our analogy woman again, but this time, everything at her work is great.  In fact, everything in her life is wonderful: work, home, finances, social life...except for her chronic headaches and migraines.  Every night, without her or her husband's knowledge, she clenches her jaw while asleep.  Not grinding her teeth, but clenching her jaw.  She therefore is making no grinding noises and there is no wearing away of her teeth.  In fact, her teeth are beautiful and her dentist has assured her that she's not grinding her teeth at all!  However, her jaw muscles have been working very, very hard.  Her teeth are being compressed and crushed into their own sockets (her teeth are sometimes sensitive to cold).  If she's clenching with her jaw set slightly to one side or the other, she's exerting tremendous strain on her jaw joints (TMJs).   The sensory component of the Trigeminal nerve is essentially bombarding her brain with noxious (negative) input. 

So now, not only does her chronic jaw clenching cause her to wake with a degree of headache (or stiff/sore neck, shoulders and/or jaw), she has become far more susceptible or irratable to her migraine triggers.  So how does one tell if they might be a chronic jaw clencher?

There are two simple questions to ask in an interview of a headache/migraine patient that tend to identify the probability of nocturnal jaw clenching.

Question 1:  On a scale of 0-10, with 10 being the worst discomfort above the shoulders that you could imagine (includes neck, jaw, sinus, headache or migraine pain),  and 0 being no pain at all, how many mornings per week do you wake with a ZERO, that is, you feel fabulous? 

That last part needs to be emphasized.  To anyone else, not having pain upon waking is normal.  Sure, you can still feel tired, but a lack of pain isn't remarkable to the normal person.  For the chronic headache and migraine pain sufferer, some degree of pain/discomfort above the shoulders is normal.  For them, having no discomfort at all would be, well, fabulous.  Perhaps unintentionally, the chronic headache and migraine pain sufferer avoids that acknowledgement.

So when asked the above question, most chronic migraine sufferers will hesitate with their reply, and then begin to rationalize their answer before they provide it.  They'll begin by stating, "Well, when I get my really bad headaches...", or, "Nobody ever really feels fabulous", or some justification as to why it's "within normal limits" for them to have discomfort upon waking.  The practitioner must press on, and confirm how many mornings per week that the patient wakes with ZERO pain.

Experienced practitioners will soon find that being completely pain free every morning upon waking is quite rare for the chronic migraine sufferer.  The practitioner can remind the sufferer that waking daily with, say, liver pain or kidney pain is certainly not normal, and so it is with chronic headache pain.  The most effective migraine prevention treatment plan cannot be provided to its fullest extent if their entire presentation is not understood.

Question 2:  On those days that you don't wake with a ZERO (that is, you have "a number"), what's the average "number" that you have?

Now the practitioner will have a clearer picture of the patient's condition and likelihood of the presence of nocturnal jaw clenching.  For example, waking 5 days per week with a level 4 headache, to some chronic sufferers, is not worthy of reporting.  They have learned that they must deal with their discomfort and reserve their complaints for the degree of migraine pain that alters their daily lives.  They are wary of being labeled "drug overuse" patients, because in some practitioners minds, constant headache, especially upon waking, could only be due to medication overuse.  Chronic jaw clenchers will wake "with a number" more times than not, with the intensity varying, depending on the intensity of clenching the night before.  Although waking with a 4 to a 6 wouldn't be unusual, waking with an 8 or 9 does not surprise them (while waking with 0 would be very surprising).  To them, it's something that happens, and if they can get on with their day, they try to ignore it.

The chronic migraine sufferer eventually succumbs that their worst headaches and migraine attacks are far more important to try and manage than their chronic "normal discomfort" existence.  Besides, no one has been able to diagnose and alleviate their normal discomfort, anyway.   However,  to the practitioner, this information is critical in the assessment of the cause and/or perpetuation of their patient's condition.

This is not to suggest that chronic nocturnal masticatory parafunction (i.e., intense jaw clenching) is the cause of chronic headache or migraine pain.  On the contrary, it is better considered as being a primary complicating factor and/or perpetuating influence on chronic headache and migraine pain.  Better stated, habitual nocturnal jaw clenching cannot, by itself, cause chronic headache or migraine pain, but chronic headache and migraine pain cannot be completely managed and prevented in the presence of undiagnosed and uncontrolled nocturnal jaw clenching.  In fact, without controlling nocturnal jaw clenching, traditional medical attempts at migraine prevention may fail altogether. 

So how is jaw clenching controlled?  There are three aspects of jaw clenching to consider; the frequency, the duration, and the intensity.  The first two, frequency and duration, cannot be controlled.  The clencher will close and squeeze no matter what's in their mouth and will remain clenching with a duration that is unique to them.  The number of times they clench, and the length of time per clench, cannot be controlled.  However, it's the intensity of the clenching that is problematic. 

In order for clenching to achieve pathologic intensities, the back molars and/or canine (fang) teeth must come into contact with either each other, or with an object sandwiched between them. Some people use a common "nightguard" to protect their teeth from clenching.  Unfortunately for the headache/migraine patient who clenches, the nightguard allows them to clench more intensely with it than without it. 

NTI therapy uses an NTI device, which is a far smaller mouthpiece that fits only on either the upper or lower front teeth.  By preventing the molars (or canines) from engaging anything, clenching intensity cannot achieve pathologic levels.  At first one might be concerned that when using an NTI device that their clenching intensity would damage their front teeth.  However, since the back teeth cannot touch, clenching intensity remains low and tolerated by the front incisors.

Following the first month of NTI therapy, the practitioner can re-ask the two questions above.  Although the patient might first proclaim, "I'm still having headaches" (as if no improvement had occurred), the practitioner may discover that the patient is now waking less frequently "with a number" and that the level of that number has been reduced.   Continually using the two questions above is a handy tool to follow a patient's progress.

By the way, NTI stands for Nocioceptive Trigeminal Inhibition.  Essentially, the name implies that negative sensory input (nocioception) to the brain via the trigeminal nerve is inhibited by the presence of the device (which prevents high intensity jaw clenching). 

How well does it work?  In the clinical trials submitted to the FDA, 82% of migraine suffers experienced a 77% reduction in migraine pain events.  In 2001, the FDA cleared the NTI device "For the prevention of medically diagnosed migraine pain".  Note that the NTI does "cure" migraine, it reduces (sometimes to zero) the pain events and intensity.  (In this follow-up study of patients who's chronic daily headaches were deemed "severe and disabling", 65% had a 71% average reduction in their morning headache days, while 75% reported a significant improvement in the quality of their lives).

If the NTI is so effective, why hasn't it been enthusiastically embraced by the medical community?  The problem is the design of the study that was submitted to the FDA.  When a drug is tested, it is compared to a placebo, that is, a similarly shaped sugar pill.  The placebo will always produce the desired effect to some degree.  The goal is to statistically have the test drug  outperform the placebo.   For example, Botox was recently approved by the FDA for the prevention of chronic migraine.  When compared to the injection of water (the placebo), Botox patients had 1.5 more "headache free days" per month.  The advertising doesn't tell you that that means placebo patients had 16.5 headache days per month while Botox patients had 15. 

Unfortunately, there is nothing can be put into one's mouth that cannot produce sensory information, therefore, the NTI cannot be compared to a placebo mouthpiece.  Without "placebo controlled" studies, the efficacy of NTI therapy for migraine prevention is not seen as credible in medicine.

-James P. Boyd, DDS
Developer of the NTI therapeutic protocol. (more on Dr. Boyd)
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Dr. Boyd on Good Morning American, September, 2001:

More from Dr. Boyd on his background and experience in headache management:

I had been a daily headache sufferer for 12 years, from my senior year in high school in 1977, through 1989, four years out of dental school.  Each day I woke with a degree of headache, ranging from a 3 to a 6.  For the first few years out of dental school, it was rarely in the low ranges.  I consumed nearly a dozen Excedrin tablets per day. Occasionally, it would get out of control, and the nature of the pain would change from squeezing and throbbing to a degree where I was nauseous.  Later I leaned those were migraines.

As an undergraduate college student, I had been a "TMJ" patient.  My jaw would make loud popping sounds as I chewed, and occasionally would locked closed upon waking in the morning. I was treated with a "splint", a horse-shoe shaped acrylic device that covered my upper teeth.  It seemed to help for a few days, but I eventually got used to it and my headaches returned.  I learned that if I only used in for a night or two, then went without it for a night or two, then back to wearing it, I wasn't as bad. 

Three years out of dental school and my head was pounding all day long.  The really frustrating part was that my dental practice emphasized "TMJ treatment", yet I was unable to help myself.  The splint I had used while in college helped some patients, but many seemed just like me.  No matter what I tried, their headache symptoms persisted. 

In 1988 I recalled a lecture I had been to a few years prior, given by one of the experts in Temporomandibular Disorders (the proper name for TMJ).  He had said that for the patient in "muscular distress" (meaning clenching like crazy), to place an anterior midline mound on the patient's splint (in dentistry, that's called a "deprogrammer").  Allow the patient to become comfortable over a few days, then remove the addition.   Practically in desperation, I added a small elevated mound at the front midline of my splint, so that when I closed my mouth, only the edges of my lower front teeth contacted the mound.  No other teeth touched anything.

For me, it was nothing short of miraculous.  The next day I woke without a headache.  Although it creeped back somewhat later in the day, it was nothing like I was used to.  The next three days was the same lack of the usual morning headache.  Things were going great until the end of the week when I woke with a type of headache that I was completely unfamiliar with.  Pain behind my eyes and at the base of my skull.  I assumed this was why I had been instructed to remove the mound after a few days...apparently,  it would eventually backfire.  However, as I assessed myself while biting on the splint, I discovered that my jaw had "learned" to shift forward enough to avoid the mound!  I had learned to clench my back teeth by shifting my jaw forward, thereby also changing the presentation of my headache

So I began my personal education of the variability of jaw clenching activity.  It's not the same for everyone.  It's as if the jaw clenching activity looks for a way to maintain itself, doing whatever it takes (like moving way off to one side, forwards, backwards, whatever) to accomplish the goal of making the patient miserable.  A simple mound on a splint would fail miserably in most sufferers, as their jaw would shift to clench elsewhere, usually making the patient feel worse.  So over the years, dentists had already learned that a deprogrammer should not be used for more than a few consecutive nights.  No one really knew why, just that the relief just didn't seem to last.  But I wasn't just the dentist.  I was the patient, so I set about "enhancing" the deprogrammer.  The shape of the mound changed, anticipating the extremes of jaw movements, allowing for a continuous midline contact on the lower teeth no matter where the jaw went.  As it turned out, the enhanced design was so unique I received several U.S. and International Patents. 

Using an NTI device is certainly not without its precautions.  Unlike a medication, the efficacy of an NTI device is directly related to the practitioner's ability, knowledge and insight.  The jaw clenching activity may alter its patterns, making the patient present as a "new patient" each time they're seen by their dentist, so he to be on the lookout.  The jaw joints are like no other in the human body.  Unlike a common hinge joint, the jaw joint allows the lower jaw to move up, down, forwards, backwards, side-to-side.  It's actually the jaw muscles that dictate any one position.  In some people, after using an NTI device, their jaw musculature's posture changes, after having been chronically tensed for years.  Their jaw musculature "normalizes".  As the patient's symptoms improve and the jaw muscle tension changes, the relationship between their upper and lower jaw may change, with the patient sometimes noticing a difference in their bite.  The majority of the time the change in this small minority of patients is practically unnoticeable.   However, there are cases where the change of the jaw's relationship has necessitated the patient to have orthodontics done to regain a bite relationship that is more agreeable to them.  These changes occur in the presence of an improvement of symptoms.  Although symptom reduction/elimination is the desired outcome, each patient and their practitioner must weigh their risks vs. benefits.   In this published study of 90,720 NTI devices delivered, only 1.6% of the practitioners reported undesired changes in their patient's bite. 

AMPSA CS is a registered trademark of Therapeutic Solutions International, Inc.,  a product whose technology has been licensed from Boyd Research. It is the same as the NTI-tss device and derived from the same patent.