Northstar Neuroscience has completed two feasibility clinical studies (ADAMS and BAKER) that included 32 stroke survivors with hand and/or arm disability resulting from their stroke (known as upper extremity hemiparesis). The results of these two studies suggest that cortical stimulation when combined with rehabilitation, may improve a patient’s hand/arm motor recovery more effectively than rehabilitation therapy alone.

Half of the patients were in the "control group," meaning they received rehabilitative physical therapy only without cortical stimulation. The other half of the patients were in the "treatment group," meaning they received the same rehabilitative physical therapy as the control patients and also received cortical stimulation treatment at the same time. Patients in both groups benefited from participation in the study. However, those patients receiving cortical stimulation in addition to rehabilitative physical therapy on average benefited significantly more than those receiving physical therapy alone.

Benefit was demonstrated in the patients' scores on standardized tests of hand and arm function and in patients' ability to better accomplish activities of daily living. The amount of improvement varied from individual to individual but on average patients who received the implanted cortical stimulation system improved 15-30%. Control group patients improved 0-12%.

Based on the results of the ADAMS and BAKER studies, a larger FDA approved clinical research study, named EVEREST, has recently completed enrollment at 21 centers nationwide. It is designed to investigate the safety and effectiveness of the Renova™-ST Cortical Stimulation System* in the recovery of hand and arm disability after stroke.

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

**The results of this study have not been shared with the FDA and there can be no definitive claims of safety and effectiveness until the FDA has reviewed and approved the labeling for this product.

Please note: All clinical trials have potential benefits and risks. Any prospective participant must sign an informed consent document in which these risks and benefits are outlined and must be discussed with the physician/institution participating in the clinical research. Once the informed consent is signed the patient may be enrolled in the clinical trial. All information collected about patients is subject to protection under a Federal law known as “HIPAA.” More information about informed consent and the protection of the patient’s personal information is provided to prospective clinical trial participants when they inquire about being involved in the clinical trial.