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FDA Approves Neuromuscular Suppression Device for the prevention of Migraine pain and associated chronic tension-type headaches.
82% of migraine sufferers had a 77% reduction in migraine events within 8 weeks and continue to improve.
Mishawaka, IN, July 10, 2001 The FDA has granted marketing allowance for the NTI
Tension Suppression System (NTI-tss) neuromuscular suppression device indicated for
the prevention of medically diagnosed migraine pain and migraine associated tension-type
headaches.
In a multicenter trial, the NTI-tss device was shown to considerably reduce or eliminate migraine and migraine associated tension headache pain. It is considered breakthrough migraine technology in that there is, when used as directed, no risk of side-effects associated with it compared to many current pharmaceutical migraine preventatives.
Patients who experience migraine headaches typically contract their temporalis muscles (which
cover the entire sides of the skull and are the most powerful muscles of the body) during sleep on
average 14 times more intensely than those who do not experience them, and have been found to
exhibit “pericranial tenderness” (muscle tenderness of the scalp), setting the stage for migraine and
tension headache attacks. Typical migraine sufferers awake nearly every morning with varying
degrees of headache pain but have come to accept headaches as normal and unremarkable. The
NTI-tss device is a small, removable, prefabricated matrix which a dentist custom fits to a patient’s
front teeth to be worn while sleeping. With the NTI-tss device in place, the intense activity of the
temporal muscles (which close and clench the jaw) is suppressed to less than 1/3 of maximum by
preventing any contacting of the back molar or canine teeth. By reducing this neuromuscular activity,
migraine headache pain attacks are reduced or prevented all together, as well as the migraine
associated tension-type headaches.
23 million people older than 12 years of age suffer severe migraine headaches. The social and
economic impact of migraine is staggering, with estimates approaching $17.2 billion per year lost in
productivity (The 1992 American Migraine Study, Journal of the American Medical Association)
The NTI-tss trial compared the effect of the NTI-tss device to a control device on medically
diagnosed migraine sufferers. Each subject had at least 2 migraines per month and had a physician’s
prescription for Imitrex (sumatriptan, GlaxoSmithKline) as a migraine rescue medication.
After eight weeks of using the NTI-tss:
- There were no side-effects and no new pain;
- 82% of NTI-tss 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%