Central DuPage Hospital (CDH), in Winfield, 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, 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.