A recently launched clinical research trial at Scripps Memorial Hospital Encinitas is exploring whether a new treatment using infrared energy can be effective in improving outcomes for ischemic stroke patients.
Ischemic stroke, caused by a clot or other blockage within an artery leading to the brain, affects more than 600,000 people in the United States each year and accounts for almost 80 percent of all strokes. When the blood supply to the brain is blocked, brain cells that are unable to receive enough blood and oxygen die, which may result in disabling injury or death.
Current treatments available for patients with acute ischemic stroke are limited to medications or techniques to re-open a blocked artery and must be used in the first few hours after the stroke occurs. The noninvasive laser technology being used in the Scripps Encinitas trial can be applied up to 24 hours after the onset of stroke symptoms and is believed to work by stimulating metabolic reactions in brain cells and mitigating cell death.
The randomized, double-blind trial will enroll up to 660 patients who have suffered ischemic stroke within 24 hours of arriving at Scripps Encinitas. The clinical trial is utilizing technology developed by PhotoThera Inc. of Carlsbad, Calif. The NeuroThera® Laser System therapeutic approach involves the use of infrared laser technology administered through the patient’s skull and into damaged brain tissue. Patients wear a specially designed skullcap with 20 pre-identified areas for the neurologist to administer the treatment via a specially designed hand piece and single-use TheraLens™.
“For years, the medical community has been looking for a treatment to help salvage brain cells that are stunned or injured and at risk of dying after stroke,” said Thomas Chippendale, M.D., a Scripps neurologist and lead investigator for the Scripps Encinitas clinical trial. “To date, no medication has been approved for this purpose, but the use of infrared light is a unique strategy to help injured cells survive.”
Patients entered in the trial will receive a single treatment, which involves a procedure time of approximately one hour. PhotoThera has completed an initial, randomized human trial on 120 patients and based on prior results has received approval from the Food and Drug Administration to sponsor the current multi-center trial.
Dr. Chippendale said it is absolutely critical to educate people to understand the symptoms of a stroke, and to get to the hospital immediately after symptoms become evident. The most common signs and symptoms of stroke include:
H – headache sudden onset
E – eye problems (blurred, decreased or loss of vision)
L – language problems
P – paralysis or inability to move one or both sides of the body
Scripps Memorial Hospital Encinitas is a recognized leader in stroke care. In 2006, the hospital was recognized with a gold seal of approval as a certified primary stroke center – the first hospital in San Diego’s North County to earn this accreditation from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The Scripps Transition After Rehabilitation Treatment (or START) program provided services to more than 850 people in San Diego’s North County in 2006, including those affected by stroke, spinal cord injuries and neurological conditions. Scripps Encinitas also has a long-established rehabilitation department, which is accredited by CARF (Commission on Accreditation of Rehabilitation Facilities), considered the “gold standard” in rehabilitation services.
Scripps Memorial Hospital Encinitas offers a full range of clinical and surgical services, including 24-hour emergency services; intensive care; cancer/oncology; orthopedics; neurology; urology; ophthalmology; a Level II neonatal nursery; award-winning OB/GYN and maternal and baby health services; and an ambulatory surgery center. With 138 beds, more than 1,000 employees and 550 affiliated physicians, Scripps Encinitas is part of the Scripps Health system serving the growing communities of San Diego’s coastal North County.