A potential new therapy to prevent crippling brain damage after a stroke could one day help save lives or prevent paralysis in millions of people globally.
Brain cooling has been shown in studies to decrease brain swelling and reduce loss of neurological function after acute stroke. Now, thanks to approval from the U.S. Food and Drug Administration (FDA), an international multicenter clinical trial led by Patrick D. Lyden, MD, will expand from 50 to 400 patients. Dr. Lyden is chair of the Department of Neurology and director of the Stroke Program at Cedars-Sinai.
The study uses brain cooling, or “controlled hypothermia,” with “clot-busting” drug therapy. Hypothermia has proved highly effective in saving lives and preventing neurological damage after heart attack or oxygen deprivation in newborns.
Researchers employ a state-of-the-art temperature modulation system that provides quick and controlled cooling through a catheter inserted into the inferior vena cava—the body’s largest vein. The catheter’s internal circulation system absorbs body heat and transfers it out, which slows metabolism, keeps tissue swelling in check, and gives the brain time to rest. Body temperature is cooled to about 90 degrees Fahrenheit for 24 hours, then patients are gradually warmed.
The study combines brain cooling with tissue plasminogen activator (TPA) drug therapy. Given as quickly as possible after stroke onset, TPA sometimes dissolves a clot and prevents or reduces serious brain injury. Dr. Lyden, the Carmen and Louis Warschaw Chair in Neurology, helped lead the pivotal clinical trial of TPA that resulted in its approval by the FDA in 1996.