A groundbreaking clinical trial to prevent paralysis and death right after a stroke by cooling the brain is underway, led by Cedars Sinai, that researchers say could change everything.

The trial has been boosted from 50 to 400 patients with FDA approval, and used both “controlled hypothermia” and a “clot-busting” drug therapy. It is showing solid results in reducing neurological damage that leaves people devastated after a stroke.

Here’s how it works:

Dr. Patrick Lyden, chair of Cedars-Sinai Department of Neurology, the principal investigator, along with doctors from UC San Diego, University of Texas and other nations, are testing on humans a state-of-the-art system that quickly cools the head while keeping the body relatively warm.

This is achieved using a special catheter placed into the inferior vena cava, the largest vein carrying de-oxygenated blood from the lower body to the heart. Doctors lower a stroke victim’s body temperature from 98.6 degrees to just 91 degrees for a full day, then gradually warm them back up.

The catheter contains no fluids, but is instead used to push and “internally circulate” the patient’s own blood, then “transfers it out to slow metabolism.” This process lowers tissue swelling and lets the brain rest.

Dr. Patrick D. Lyden, Cedars-Sinai neurologist; Credit: Courtesy of Sandy Van/ PR Pacific

Dr. Patrick D. Lyden, Cedars-Sinai neurologist; Credit: Courtesy of Sandy Van/ PR Pacific

Although it sounds invasive,
Lyden, explains to L.A. Weekly, “The procedure is well-tolerated. You and I imagine being cold as quite painful, but in fact we are cooling patients to 90 degrees Fahrenheit internally. We also provide them with mild sedation and blanket-warming.”

The patients are covered with temperature sensors and a blanket that tricks the body into feeling warm. A mild sedative helps stop shivering, an uncomfortable effect of the warm/cooling system. Recent advances in the treatment help curb even these side effects.

Lyden explains, “The main new change is that we added precautions to prevent pneumonia, because when you actively chill a patient its possible to induce pneumonia. The main new development here is we altered the cooling procedure.”

This new treatment could one day save lives or prevent terrible paralysis in millions of people globally. In the U.S., 700,000 people suffer a stroke every year, 500,000 of them for the first time.

After decades of frustrating efforts to find a better treatment, clinical trials showed that serious brain injuries can be prevented — and treatment can dissolve a blood clot quickly after stroke onset.

The brain-cooling clinical trials (ICTuS, Intravascular Cooling for Acute Stroke) are supported by grants under the Specialized Program for Acute Translational Research at the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.

A UC San Diego grant is funding 18 study sites where stroke victims agree to participate in the clinical trial. A University of Texas Health Science Center grant funds eight sites. Most locations are in the U.S., but some are in Europe.

Lyden also developed a drug approved by the FDA in 1996 that’s being used in the trials.

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