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BrainsGate Stroke Research at Erlanger

by on April 6, 2010

Erlanger Health System is one of 6 hospitals in the United States participating in a clinical trial of a novel device called the Ischemic Stroke System (ISS) that may greatly increase the window of treatment for stroke victims. Current treatments allow for a maximum of 8–9 hours before irreversible tissue loss occurs. The ISS treatment would extend that window to 24 hours.

Created by BrainsGate Ltd., an Israel-based medical device manufacturer, the ISS uses an implantable electrode and is designed to deliver electrical stimulation to the Spheno-Palatine ganglion (a parasympathetic nerve center located near the sinus cavities behind the nasal cavity). Once activated (using an external system temporarily attached to the patient’s cheek), the system augments blood flow to the patient’s head. In the case of ischemic stroke, the treatment is administered over a number of hours or days. This stimulation  leads to a gentle increase of blood flow to the brain aiding in the management of ischemic stroke.

The device must be implanted through the roof of the patient’s mouth into a small canal between the sinuses. Until recently, this had to be accomplished mainly by sight and feel. However, that changed last month when the Erlanger team was the first to use a new high-tech navigation system called Guideview. Utlizing the international audio-visual telemedicine capabilities of the Guideview System, the team was able to consult in real-time with Israel-based representatives of BrainsGate through an internet connection.

How it works

The ISS is an investigational device currently undergoing clinical studies to determine its safety and effectiveness in patients with acute ischemic stroke. It is implanted in a minimally-invasive procedure under local anesthesia.

The ISS is comprised of the following components:

  • A miniature implantable neurostimulator (INS) – an electrode-equipped implant that is placed adjacent to the Spheno-Palatine ganglion in the palatine canal. The INS is inserted into the palatine canal through the greater palatine foramen near the third molar, making the implantation a simple procedure.
  • A driver worn by the patient on an armband during stimulation sessions.
  • A transmitter placed on the patient’s cheek, held by a headset to transmit electrical energy from the driver to the implant.
  • A controller that allows the caregiver to set treatment parameters and view the system logs.

Device images

Device compared to toothpick (click image to enlarge)

ISS device compared to a dime (click image to enlarge)

image source: www.brainsgate.com

image source: www.brainsgate.com

To see how the ISS is used to treat stroke victims click here.

Links:

BrainsGate company Web site

Southeast Regional Stroke Center at Erlanger

The Erlanger Team

Peter Hunt, MD

The Erlanger surgical team is led by Dr. Peter Hunt, otolaryngologist with Associates in ENT, Head, and Neck Surgery.

Thomas G. Devlin, MD PhD
Thomas Devlin, MD

He is assisted by Tom Devlin, MD, PhD, Medical Director of the Southeast Regional Stroke Center at Erlanger and principle investigator for this research trial.


From → Clinical Trials

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