Northstar Neuroscience  
Stroke: Aphasia
Renova-ST™ Cortical Stimulation System
Background
Scientific Literature

 


Background

According to the American Stroke Association, there are over 5.7 million stroke survivors in the United States, of whom nearly 20% suffer from language impairment. Following a stroke, the only treatment currently available for patients with Broca’s aphasia is rehabilitative speech and language therapy. Unfortunately, many patients do not achieve satisfactory functional improvement from rehabilitative therapy alone.

There is considerable evidence that the brain can undergo significant reorganization after an injury such as a stroke by a process termed neuroplasticity, a natural process by which existing neurons and alternate neural pathways in remaining healthy brain tissue assume some of the capabilities previously controlled by the parts of the brain damaged by a stroke. Within hours after a stroke, the brain will begin to recruit existing alternative neural pathways in an attempt to meet functional demands. However, natural gains in speech generally plateau within several months after a stroke, with many stroke survivors achieving only minimal recovery of function. Most patients today do not receive post-stroke rehabilitation beyond an initial period; instead, they must live with and adapt to their disabilities. These disabilities inhibit patients’ ability to communicate effective and negatively impact their quality of life.

Northstar Neuroscience has developed the Renova-ST™ Cortical Stimulation System* intended to enhance neuroplasticity and recovery of function in patients who suffer from Broca’s aphasia. Our initial research, the CHESTNUT feasibility study, has shown that cortical stimulation, in conjunction with intensive speech and language therapy, may meaningfully enhance speech and language function beyond natural recovery, even in stroke survivors who receive our cortical stimulation therapy several years after their strokes.**

*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.