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Neuralieve’s device treats migraine headaches without medicine, says study

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Thursday, March 4, 2010, 15:44 This news item was posted in medical devices category and has 0 Comments so far.

A non-drug device by Neuralieve has been found effective in treating migraine headache in clinical studies.

Neuralieve’s headache management system includes a portable Transcranial Magnetic Stimulation (TMS) device that will allow patients to deliver migraine treatments at home.

The device is yet to cleared by US FDA.

Transcranial Magnetic Stimulation TMS, may be effective in interrupting or short-circuiting the progression of abnormal signals, potentially stopping or minimizing the migraine attack, researchers found.

TMS technology has been used for many years to study the circuitry, functionality and connectivity of the brain. With TMS, brain activity can be triggered without discomfort, since the patient cannot feel the magnetic pulse. The most robust and widely-accepted use of TMS is in measuring the connection between the primary motor cortex and muscles.

This is most useful in monitoring stroke, spinal cord injury, multiple sclerosis and motor neuron disease.

TMS is based on the principals of induction—rapidly changing magnetic fields that induce electrical currents.

When TMS is applied to the back of the head, these mild electric currents pass non-invasively through the skull and tissue to excite and depolarize neurons in the brain.

This process is thought to short circuit the abnormal electrical activity associated with migraine and cortical spreading depression (CSD).

Neuralieve technology utilizes single pulse Transcranial Magnetic Stimulation or sTMS.

The investigational device delivers each treatment in a milli-second (1/1,000 of a second). By comparison, a typical magnetic resonance image (MRI) device continuously delivers a magnetic field more than twice as strong with each session lasting over 20 minutes.

Neuralieve reported positive data on the mechanism of action of TMS technology for the treatment of migraine aura.

The results demonstrated the effects of Transcranial Magnetic Stimulation (TMS) on cortical spreading depression (CSD) in rats.

“These data demonstrate a biological rationale for the use of TMS to treat migraine aura,” stated Dr. Goadsby, lead investigator of the study.

CSD, the animal correlate of migraine aura was susceptible to TMS, with the wave of neuronal excitation blocked on over 50% of occasions, he added.

What is migraine?

In a previously conducted randomized controlled clinical study for migraine with aura, treatment with Neuralieve’s non-drug, non-invasive TMS device was found to be superior to the placebo control, and led to patients being pain-free at 2 hours, 24 hours and 48 hours.

A migraine is a chronic and often debilitating neurological disease that affects nearly 12% of the world’s population.

Symptoms typically include excruciatingly painful headaches, nausea and sensitivity to light and sound. More than half of migraine patients report severe impairment or require bed rest during their episodic attacks.

The average migraine patient experiences 2 to 4 episodes a month. Women are nearly three times more likely to be affected than men.

Migraines are most common during a person’s highly- productive years, between the ages of 15 and 55. The National Headache Foundation estimates that migraines result in 157 million lost workdays each year, with a cost burden of $13 billion to American employers.

An estimated 30 million Americans suffer from migraines.

The precise cause of migraine is not completely understood. However, migraines are often initiated by triggers, which may include specific foods, smells, moods, light patterns, hormonal alterations, alcohol or caffeine changes, sleep disturbances and other causes.

Migraine is believed to be a disorder in the area of the brain involved with sensory processing modulation, which causes an abnormal or hyperexcitable response to normal sensory input or triggers.

This creates an “electrical storm,” which, in turn, causes the migraine. Hyperexcitability of the occipital cortex neurons may also trigger cortical spreading depression or CSD, which is found in migraine with aura.

About a third of migraine sufferers experience these auras or visual disturbances prior to the onset of pain. Numerous brain scans using Positron Emission Topography, or PET scans, have confirmed the presence of CSD in migraine aura.

Migraines are typically treated with prescribed medication and over-the-counter pain killers.

Although current treatment options are effective for some, studies have shown that about 70% of migraine patients are not satisfied with current options or cannot tolerate the side effects associated with medications.

Neuralieve is a private a medical technology company specializing in migraine located in Sunnyvale, California.

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