| 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.
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