Drug-free migraine pain prevention device proves effective in 82% of patients

FDA grants approval; no drugs, no surgery, no side-effects

SAN DIEGO, CA – A device recently approved by the Food and Drug Administration (FDA) has been proven to be effective in significantly reducing headache pain and migraine-related episodes.  82 percent of those patients studied had a 77 percent average reduction of migraine pain events within the first 8 weeks of use, and were continuing to improve.

The device, called the NTI Tension Suppression System (NTI), is remarkably simple, safe, and effective. For the 28 million Americans who suffer from migraines, the device is a breakthrough.

“The reason this device is innovative is because it addresses a contributing source of the problem, rather than just ‘covering up’ the symptoms,” said device inventor and NTI-TSS CEO James Boyd, D.D.S. “It seems that in our society, we believe that a cure has to involve medication or complex surgery. This device goes against all that, with a concept so simple that a child can understand how and why it works.”

To understand the “how and why,” it is important to note that most migraines, characterized by severe headache accompanied by nausea or sensitivity to light or sound, and common tension headaches fall into the classification of “primary headache”, that is, meaning nothing physically wrong can be found with the sufferer.  Both tension headache and migraine sufferers exhibit “pericranial tenderness”, sore and tender muscles of the scalp, known to be caused by intense contractions during sleep.  These scalp muscles, most notably the temporal muscle which covers the entire side of the skull, clench the jaws together with tremendous intensity, many times per night, often without the sufferer’s or doctor’s awareness.

 It is the intensity of this clenching that is at the root of the problem. Patients who experience chronic headaches typically contract their temporalis muscles, some of the most powerful muscles in the body, during sleep on average 14 times more intensely than those who do not experience them. The fatigued and overworked state of the musculature leads to chronic headache and an increased susceptibility to migraine attacks.

The NTI device suppresses the muscle contraction intensity that causes and/or perpetuates the problem. To best understand how it works, clench your teeth together and feel how strongly your temporalis muscles contract. Now put a pencil between your front teeth and try to do the same thing. It is physically impossible to generate an overly intense contraction.

“Medication simply addresses the symptoms,” explained Boyd. “I felt it was important to disrupt the activity that was causing the symptoms, which meant suppressing the clenching during sleep.”

The NTI-tss is small, comfortable, and worn only while sleeping. It can be fabricated by a dentist in a single visit, and, when used as directed, has no risk of side effects.

Clinical trial results submitted to the FDA studied 100 medically diagnosed migraine sufferers, all of whom had at least two migraine episodes per month (usually many more), and all of whom had a physician’s prescription for Imitrex (sumatriptan, GlaxoSmithKline) to take in the event of migraine attack. Half of those studied used the NTI device, and the other half used a control device that did not suppress clenching.

After eight weeks, results indicated a significant reduction in pain and migraine-related symptoms:
- 82% of NTI users had a 77% average reduction in migraine events
- Imitrex use was reduced by almost 50%
- Nausea episodes were reduced by 78%
- Light-sensitive episodes were reduced by 66%
- Sound-sensitive episodes were reduced by 68%
- There were no side-effects and no new pain

Eight-eight percent of women and 68 percent of men have suffered tension-type headache, while migraines affect 28 million Americans, or 13 percent of the population. Migraines cost American employers $13 billion per year due to missed work and reduced productivity* .

Boyd developed the concept and prototype version of the NTI-tss 12 years ago to treat his own migraines, which had become so frequent and extreme that they were interfering with his personal and professional life. NTI-TSS, Inc. is based in San Diego, California. For more information on NTI-tss, see www.nti-tss.com; for information on Boyd, see www.DrJimBoyd.com.  To arrange an interview, contact Danna Korn, (858) 395-5421 or This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

*National Headache Foundation, October 2001