| This feasibility study is designed
to evaluate the Northstar Stroke Recovery System*
(cortical stimulation device) to determine its safety
and effectiveness to improve the speech of chronic
stroke patients with Broca’s aphasia. Broca’s aphasia
is the inability to speak or to organize muscular
movements of speech.
For answers to the following questions, click on
the links below:
What are
the details of this clinical study?
An initial screening process will assess whether
you meet the basic 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 above 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) Stroke Recovery Treatment
System components (see the Product
section for more information) and then undergo a
speech-language therapy program. The device is activated
only during the speech-language therapy sessions.
Note: the stimulation delivered during the sessions
should not be felt. The implanted cortical lead
and IPG are removed approximately 2 weeks after
the speech-language therapy is complete.
- The control group
will participate in the same speech-language therapy
sessions but will not have the cortical lead and
IPG implanted.
- Both groups will receive
speech-language therapy sessions. During these sessions,
the participants will work with a speech-language
pathologist and participate in some computer based
speech-language training.
After speech-language 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, speech-language therapy sessions and follow-up
visits, will be 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 aphasia study?
You may be a candidate for this study if you are
a native English speaker over 21 years old
who has experienced a stroke at least 12 months
ago that caused Broca’s aphasia
(difficulty speaking and perhaps understanding spoken
words). Other inclusion criteria for the study do
exist. Some additional criteria are listed below:
- One must be able
to attend daily treatment sessions for 6 weeks.
- One must be willing
to undergo surgery if randomized to that study group.
- One must have experienced
an ischemic (“clotting”) stroke versus a hemorrhagic
(“bleeding”) stroke
The best way to find out if you, or someone you know,
qualifies for the aphasia study is to call one of
the research centers and participate in a short initial
phone screen. Contact information is provided below:
Where can I
get more information?
Two sites are currently enrolling participants for
this study.
-
The Rehabilitation Institute of Chicago, in
conjunction with the University of Chicago
Call the Center for Aphasia Research at
312-238-6163 for your initial screen.
- The University of Arizona-Tucson, in conjunction
with the University of Chicago
Please call the Department of Speech, Language
and Hearing Disorders at 520-621-9878 for your initial
screen.
If you do not live in the Chicago or Tucson area
but are interested in participating at a different
clinical site in the future, please e-mail your contact
information to aphasia@northstarneuro.com.
Your information will be saved and you will be contacted
at a later time if we expand our study to a larger
number of U.S. hospitals.
* Caution: Investigational device. Limited by Federal
(or U.S.) law to investigational use. |
