This study evaluates the Northstar Stroke Recovery System* (cortical stimulation device) to determine its safety and effectiveness to improve the hand/arm function of chronic stroke patients with hemiparesis (partial paralysis or weakness on one side of the body).

Click here for a summary of the results from the first two feasibility trials for patients with hemiparesis.

For answers to the following questions, click on the links below:

• What are the details of this clinical study?
• Who can enter the Stroke Motor Recovery Study?
• Where can I get more information?

What are the details of this clinical study?

An initial screening process will assess whether you meet the basic enrollment criteria for this study.

If you meet the initial screening criteria and choose to enroll, a series of evaluation tests (including imaging of the brain) will determine your ability to participate in the clinical study. Subjects who pass the initial screening and evaluations will be randomly assigned to one of two possible treatment groups: investigational or control.

• The investigational group will undergo surgery to implant the cortical lead and generator (IPG) components of the Northstar Stroke Recovery System (see the Product section for more information) and then undergo a hand/arm rehabilitation program during which the device is activated. Note: the stimulation delivered during rehabilitation should not be felt or cause any involuntary movement. The implanted cortical lead and IPG are removed approximately two months after the stroke rehabilitation program is complete.
• The control group will participate in the same stroke rehabilitation sessions but will not have the cortical lead and IPG implanted.
• Both groups will undergo a stroke rehabilitation program. During these rehabilitation sessions, the study participant will perform exercises that are designed to make it easier to do common activities such as dressing, housekeeping and leisure activities.

After stroke rehabilitation is complete, participants will be required to return to the hospital for periodic follow-up visits.

Note: All study related medical care, including the surgery, stroke rehabilitation and follow-up visits, are provided at no cost to the participant. Transportation is provided on an as needed basis. One may also be reimbursed for minor expenses associated with the study, such as parking, childcare, a meal, etc.

Who can enter the Stroke Motor Recovery Study?

You may be a candidate for this study if you are an adult (over 21 years old) who has experienced a stroke that has left one side of your body with weakness or partial paralysis. Other inclusion criteria for the study do exist. Some additional criteria are listed below:

• One must be able to attend almost daily rehabilitation sessions for 6 weeks.
• One must be willing to undergo surgery if randomized to the investigational study group.
• One must have experienced an ischemic (“clotting”) stroke versus a hemorrhagic (“bleeding”) stroke.
• One must show some ability to move the affected hand/arm. Stroke survivors with complete paralysis of one side are excluded from the current study.

The best way to find out if you, or someone you know, qualifies for the study is to call our medical professionals at 888-546-9779 and go through an initial phone screen or email our nurse specialists at nurse@everest-trial.com.

Where can I get more information?

If you are interested in participating in this study or would like more information, please call 888-546-9779 today for your initial screen. Basic questions can be answered during your initial phone screen. If you qualify and/or have more detailed medical questions, your name will be forwarded to the study nurse at the institution closest to your home.

The following centers are currently enrolling patients. You may also email our nurse specialists at nurse@everest-trial.com.

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