Virginia Beach, Va.
- April 6, 2007
-- Neurologists at Sentara Virginia Beach General Hospital
are participating in a multicenter clinical trial evaluating the safety and effectiveness of NeuroThera™--a non-invasive, infrared laser device being evaluated for use in the treatment of ischemic stroke.
Ischemic stroke occurs when a vessel supplying blood to the brain becomes blocked by a clot or buildup of plaque or ruptures so brain cells don’t get the flow of blood that they need. Brain cells that are unable to get enough blood and oxygen die, which may result in a disabling injury or death. The American Stroke Association estimates that each year about 700,000 people suffer a new or recurrent stroke in the United States. Over 150,000 of these people die, making stroke the third leading cause of death and a leading cause of serious long-term disability in this country.
“The greatest potential benefit of this treatment versus traditional drug-therapy treatment for stroke is that it can be administered to patients up to 24 hours after the onset of stroke symptoms. Approved drug therapy, such as tPA, must be administered within just three hours after symptoms arise. Most people who suffer from strokes don’t get to the hospital that quickly,” explained Dr. Sidney Mallenbaum, medical director of the stroke center at Sentara Virginia Beach General Hospital.
The NeuroThera™ technology works by transmitting specific infrared wavelengths through the skull in 20 specific sites. Patients wear a specially designed skullcap with pre-identified areas for the neurologist to place the infrared beams. The technology is believed to work by stimulating metabolic reactions, preventing brain cells from dying.
PhotoThera, the company that developed NeuroThera™, has completed an initial, randomized human trial on 120 patients called the NEST-1 study. Based upon the positive results of that trial, the Food and Drug Administration agreed to proceed with NEST-2, the current clinical trial. It is expected that 660 U.S. patients between the ages of 40 and 90 will participate in this randomized, double-blinded study at 50 medical centers across the country.
Dr. Mallenbaum is the principal investigator of the clinical trial at Sentara Virginia Beach General Hospital. “It is absolutely essential that we do a better job of convincing more of the 700,000 stroke victims per year to get to the hospital quickly,” Mallenbaum said. “We want to save lives and prevent the disabling effects of stroke.”
General risk factors for stroke include family history of stroke or heart disease, age, gender, medical history and race; modifiable risk factors include high blood pressure, undesirable levels of cholesterol and diabetes and lifestyle risk factors include cigarette smoking, obesity, use of birth control pills, excessive alcohol consumption, drug abuse, and physical inactivity.
The most common signs and symptoms of stroke include: H
– headache sudden onset E
– eye problems (blurred, decreased, double or loss of vision) L
– language problems/lightheadedness (slurred speech, difficulty understanding
speech, dizziness, loss of balance or unexplained falls) P
– paralysis, or the inability to move one or both sides of the body, weakness or numbness HELP = Call 911 immediately.
The Stroke Center at Sentara Virginia Beach General Hospital is also involved in a number of other clinical trials, all designed to reduce the impacts of stroke and provide improved neurological outcomes for patients.
PhotoThera, a San Diego medical company, is focused on helping ischemic stroke and traumatic brain injury with its energy-based technology. 20/2007