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Do you have weakness in your hand/arm due to a stroke? Click to find out how you or a loved one may qualify for this study

Salt Lake City, Utah
January 29, 2007

Northstar: EVEREST

Safety and Effectiveness of Cortical Stimulation in the Treatment of Upper Extremity Hemiparesis

The University of Utah is seeking patients who have suffered a stroke to participate in a clinical trial.

If you have suffered a stroke and have weakness in one hand and/or arm as a result, you may be eligible to participate in an investigational study to assess the safety and effectiveness of an implanted device* in treating patients who have reduced hand and/or arm function after stroke. The study compares electrical stimulation plus rehabilitative therapy to rehabilitative therapy alone. Patients must be at least 21 years old and the stroke must have occurred at least four months ago. The Food and Drug Administration (FDA) has granted approval for this investigational study to be conducted at a number of investigational sites nationwide, including The University of Utah.

Description of study participation:

• An image of the brain by functional magnetic resonance imaging (fMRI) will be used to identify the region involved in function of the affected hand and/or arm. Patients must not have any conditions which could interfere with magnetic resonance imaging (such as a pacemaker or other metallic material in the body or anxiety in enclosed or tight spaces).
• Patients will be randomly assigned to one of two treatment groups. Both treatment groups will participate in six weeks of intensive rehabilitative therapy.
• Patients randomized to the study arm will undergo two surgeries. In the first surgery, a neurosurgeon will place an electrode on the layer covering the brain (the dura) over the affected area identified in the fMRI scan. The electrode will be connected to a pulse generator (similar to a pacemaker) implanted below the collarbone. Stimulation will be below the level of sensation (or movement) and will be administered during rehabilitation sessions only. The second surgery will be performed to remove the system approximately eight weeks after conclusion of the rehabilitation period.
• Participation in the research study will last for approximately 33 weeks after randomization to a treatment group. In addition to the six weeks of rehabilitation activities, participation will also require several visits to the study center for assessments following rehabilitation.
• Patients must be able to understand and sign the Informed Consent and follow directions.
• All costs are paid for by a research grant from the study sponsor (Northstar Neuroscience, Inc).

Inclusion / Exclusion Criteria (partial list)

• Patients must be at least 21 years old.
• Patients must have had a stroke four months ago or longer.
• Patients must have weakness in one hand and/or arm.

The study is sponsored by Northstar Neuroscience, Inc. NorthStar

To learn more, please contact:
Jolee Mougey, Study Coordinator
30 N. 1900 E., 3R 226
Salt Lake City, Utah 84132
(801) 581-6291
E-Mail: jolee.mougey@hsc.utah.edu

* Caution: Investigational device. Limited by Federal (or United States) law to investigational use.

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