Researchers at University of North Carolina Hospitals in Chapel Hill have joined a large international study to determine the effectiveness of near-infrared laser light therapy delivered to the brain within 24 hours of a stroke.
The treatment involves a handheld device attached to laser generator via a fiber-optic cable. The device (it resembles a shower head) delivers high-intensity near-infrared laser light through the skull and deep into the brain. At the wavelength delivered, it is thought the light helps generate cellular energy to brain areas affected by the stroke.
“It buys the brain time to restore blood flow to the area by providing a limited amount of energy,” said Dr. David Y. Huang, assistant professor of neurology in the UNC School of Medicine and associate director of the UNC Stroke Center at UNC Hospitals.
Huang is principal investigator for the UNC study site, one of five in North Carolina. Other sites include Moses Cohen Memorial Hospital in Greensboro; Forsyth Medical Center in Winston-Salem; Mission Hospitals in Asheville; and Duke University Medical Center in Durham.
“North Carolina has the most study sites of any state, likely because we have a broad demographic representation of the types of people at risk for stroke plus a number of very good stroke centers,” Huang said. He said he hopes to treat about a dozen patients, having already enrolled and treated three.
Stroke is the No. 3 killer in the United States. It’s also a leading cause of serious, long-term disability. Many survivors are left with mental and physical disabilities.
For strokes caused by blood clots in the brain, the only FDA approved treatment for stroke is tissue plasminogen activator (tPA). But the clot-dissolver is effective only if given promptly. Intravenous treatment must be started within three hours of the onset of stroke symptoms. Only five percent of patients with stroke receive this rapid intervention – many people don’t get to the hospital in time or awaken with stroke symptoms.
The new treatment being tested at UNC Hospitals and sites around the world could push the critical treatment time beyond 12 hours after stroke symptoms begin.
In June 2007, a report in the journal Stroke described the results of a preliminary study of the laser light therapy.
The double-blind, randomized trial enrolled 79 stroke patients, who were given active treatment, and 41 stroke patients who received sham (no laser) light treatment at an average of between 17 to 18 hours after stroke onset. Outcome measures were based on National Institutes of Health Stroke Scale (NIHSS) scores and other widely used stroke outcome measures.
More of the patients in the active treatment group had successful outcomes as measured by NIHSS (70 percent) than was the case in the control group (51 percent). The difference remained significant when stroke severity and time to treatment as well as severity alone were taken into account, the authors reported.
At 90 days, the active treatment group also showed more successful functional outcomes (59 percent) than the control group (44 percent).
Huang said the results of this NeuroThera Effectiveness and Safety Trial-1 (NEST-1) have prompted a second, confirmatory trial, NEST-2, this time with 660 patients at 50 sites in the U.S. and 10 internationally.
This trial aims to demonstrate the safety and effectiveness of the NeuroThera system, manufactured by Photothera of Carlsbad, Calif., for FDA clearance.
The principal investigator for NEST-2 is Dr. Justin A. Zavin at the University of California, San Diego.
UNC Hospitals contact: Stephanie Crayton, (919) 966-2860 or scrayton@unch.unc.edu
News Services contact: Becky Oskin, (919) 962-8596 or becky_oskin@unc.edu