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National Investigational Trial for Emergency Stroke Care At CDH: One Illinois Hospital Tests New Device That May Reverse Brain Damage Up to 24 Hours After Stroke

Posted on: Monday, 12 October 2009, 16:45 CDT

WINFIELD, Ill., Oct. 12 /PRNewswire-USNewswire/ -- Central DuPage Hospital (http://www.cdh.org) (CDH), in Winfield, Ill., is the only Illinois hospital that will participate in a national investigational trial to test the effectiveness of a device that might extend the traditional stroke treatment window from three hours to an unprecedented 24 hours.

CDH is one of only six hospitals in the U.S. making the research trial available to acute ischemic stroke patients. The investigational device is designed to bring oxygen to stroke-damaged areas of the brain in a very unconventional way. The Ischemic Stroke System (ISS), pioneered by Brainsgate (http://www.brainsgate.com/eng/page.php?id=39&instance_id=9), uses electrical stimulation of an implant placed in a small nervous center behind the nose, called the Spheno-Palatine Ganglion (SPG), to increase blood flow and bring needed oxygen to damaged areas of the brain. Typically, advanced treatment of an acute stroke requires using catheter-like tools in the tiny vessels of the brain.

"If it accomplishes what it is designed to, the Ischemic Stroke System could be a stroke treatment breakthrough," asserts Dr. Harish Shownkeen, principle investigator for this research trial, co-medical director of the Stroke and Neurovascular Program and section chief of the Neurosciences Institute at CDH. "The procedure is designed to help save brain tissue and to improve outcomes by augmenting the reversal of damage done to the brain during a stroke. Our participation in this investigational research trial will help determine if there is any benefit to the treatment."

The ImpACT-24 Multi-Center Trial Launches Oct. 16, 2009

The trial, called ImpACT-24 (Implant for Augmentation of CBF Trial in a 24 hour window), is a multi-center, multi-national study taking place over the next two years. The minimally invasive procedure lasts just 10-15 minutes and is performed under local anesthesia, much like a dental procedure.

It consists of:

- A miniature implantable neurostimulator (INS), an electrode-equipped implant, is placed near the SPG in the nasal canal. It is inserted near the third molar, making implantation a simple procedure.

- A transmitter is placed on the patient's cheek and held by a headset to transmit electrical energy from the driver to the implant.

- A controller is used to allow the healthcare professional to set treatment parameters and view system information.

"While the treatment of ischemic strokes has been growing by leaps and bounds in the last decade, this latest treatment would be a huge step forward because it could potentially extend the treatment window to 24 hours. Currently, the treatment window with FDA-approved devices is eight hours, or with another investigational device available at CDH and a few other centers is 14 hours," says Shownkeen.

Overview

Ischemic stroke is a devastating and potentially lethal event and is the second most common cause of death worldwide according to the World Health Organization. Ischemic stroke affects 750,000 Americans each year, claiming more than 150,000 lives annually.

During an ischemic stroke, blood flow to critical brain tissue is cut off and brain cells quickly begin to die. Medical attention is required immediately to prevent tissue damage.

The median time from symptom onset to emergency care ranges from four to 24 hours in the U.S. Multiple factors contribute to delays in seeking care for symptoms of stroke: patients are sleeping and symptoms are not discovered until the patient wakes; strokes may leave victims too incapacitated to call for help; occasionally, strokes go unrecognized by patients or their caregivers; patients in remote locations may be hours from a certified stroke center.

Stroke victims have a growing list of treatment options, but none that extend the window to a full 24 hours. The only current FDA-approved protocol, t-PA, needs to be administered within three hours of ischemic stroke symptom onset, so only about four percent of stroke patients receive it.

The Stroke and Neurovascular Program at CDH has been a Primary Stroke Center since 2006 and has received the Joint Commission's Gold Seal of Approval(TM). The team was also recognized in 2008 with the Gold Achievement Award from the American Stroke Association.

About Central DuPage Hospital

Central DuPage Hospital (CDH) is a nationally recognized 313-bed facility located in Winfield, Ill., a suburb west of Chicago. CDH is a leading center for medical technology and one of the busiest surgical centers in Illinois.

For the last three consecutive years, Thomson Reuters has listed CDH as a 100 Top Hospital in the U.S. Similarly, U.S. News & World Report has included CDH on their list of Best Hospitals in the orthopaedics category each year since 2007.

The hospital is part of an interdependent network of health-care organizations and services, including convenient care centers, occupational health services and a full range of options for senior living, home health and hospice care. For more information or to find a doctor on the medical staff of CDH, visit www.cdh.org (http://www.cdh.org) or call 630-933-4CDH (4234)/ TTY 630-933-4833 for the hearing impaired.

SOURCE Central DuPage Hospital

Source: PR Newswire

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