January 1, 2008

JANUARY 2008 – Stroke is the third leading cause of death behind heart disease and cancer. Stroke is the number one cause of permanent disability in the U.S., causing Americans to pay more than $57 billion in stroke-related medical and disability costs each year. A study published in Stroke: Journal of the American Heart Association reported that nearly two million brain cells die each minute a stroke goes untreated. But there is encouraging research ongoing using high-intensity infrared energy from a device applied to the patient’s head. The energy is thought to keep brain tissue alive while it's cut off from blood, oxygen and nutrients caused by a blockage from the stroke. NeuroThera, made by a San Diego company called PhotoThera, is a technology under development for the treatment of ischemic stroke. It is not approved for sale or distribution in the United States or internationally. The device is being tested by the CAMC Health Education and Research Institute Clinical Trials Center. CAMC is one of about 50 sites around the world to participate in the study. Researchers will enroll 660 volunteer participants (with about 13 from CAMC). “NeuroThera can be used to treat patients up to 24 hours after the onset of stroke symptoms,” said Kuruvilla John, MD a neurologist with privileges at Charleston Area Medical Center. “If it is proven to work, this will be a major breakthrough because, currently, the most common method of treating acute ischemic stroke is to give clot-busting medications in the first few hours after the stroke occurs. NeuroThera gives physicians more time to save more brain cells.” Approved drug therapy, such as tPA, must be administered within just three hours after symptoms present. Most people who suffer from a stroke don’t get to the hospital that quickly. At best, about five percent of stroke patients are treated. Here’s how NeuroThera works. The patient’s head is shaved. A cap, with holes in it, is then placed on the head. The physician uses the hand-held device to shoot bursts of infrared laser light in each location on the scalp for two minutes. A complete treatment takes about an hour. This is a randomized, double-blind trial with half of the patients receiving a placebo, in which the device isn't active. This is a phase III trial (referred to as NEST-2). An earlier study of 120 stroke patients found that 70 percent of patients treated with the NeuroThera device within 24 hours of their stroke improved, compared with 51 percent of patients who received placebo treatments with the inactive device.

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