To participate in this study, Additional Information... you must: University of Pittsburgh

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To participate in this study,
you must:
Additional Information...
This research study involves risks that are
1. Have limited hand function due to
cervical
s pinal
(tetraplegia),
cord
brainstem
or
typically associated with any neurosurgi-
injury
cal procedure.
spinal
search team for more information and for
stroke
Please contact the re-
University of Pittsburgh
Department of Physical Medicine
& Rehabilitation
Human Rehabilitation and Neural
Engineering Lab (hRNEL)
a description of the risks involved with
2. Be age 18-70
this study.
3. Live within 1 hour of the University of
Pittsburgh or be willing to travel to the
University of Pittsburgh once per
week for BMI training
Your participation is completely voluntary
and you may withdraw from this project at
any time.
You will be compensated $20-50 for each
study visit depending on where the visit
Are you interested in
participating in a
research study using
brain-machine
interface technology?
takes place.
Learn to grasp and hold objects using a
virtual hand.
Other research studies
The Human Rehabilitation and Neural
Additional criteria must also be met in
Engineering Lab is always looking for vol-
order to participate. We will review all of
unteers with or without spinal cord injury
the criteria you must meet in order to par-
to participate in many types of research
ticipate in the study.
studies.
Since the study involves temporary placement of arrays to evaluate their effective-
If you are interested in participating in a
ness, there is no direct benefit to you.
research study, please contact the re-
Information learned
search team to find out
through this study
how you can get involved.
will support the development of a fully
Visit our website at:
implantable
www.hrnel.pitt.edu
system.
BMI
Data collected in this study will
be used to help develop future
BMI systems.
Find out how you
can get involved!
Brain-Machine
Interface Research
The Human Rehabilitation and Neural
Engineering Laboratory (hRNEL) is conducting a study to investigate the use
of NeuroPort Arrays for brain-machine
The goal of the study is to demonstrate the
While the arrays are implanted, our research
safety and efficacy of using two arrays for long-
team will conduct BMI training sessions up 5
term recording of brain activity, which will be
days per week. However, we will work with
used to control computer cursors and assistive
you to determine the testing schedule.
technologies that help people complete activities of daily living.
interface (BMI) technology. BMI tech-
Study Procedures
nology is based on the finding that with
We have received approval from the FDA to
intact brain function, neural signals are
conduct a research study to implant the arrays
generated even though they are not
for approximately 1 year under an Investiga-
sent to the arms, hands and legs.
tional Device Exemption (IDE). As part of this
study, you will undergo two surgical procedures
approximately one year apart to implant and
remove two arrays.
Tasks include computer displays and
virtual reality environments
The goal of training is for you to learn to use
your brain activity to control computer cursors,
videos games, or assistive technology. This
will take practice and we will start with simple
computer tasks. Testing may occur at your
home or in our research laboratory.
You will learn to move a specially designed
robotic arm using your brain activity
After approximately 1 year, the arrays will be
removed. You will likely stay in the hospital for
Two small electrode arrays will be implanted in the area of the brain that
You will work with doctors, therapists
and engineers throughout the study.
controls your movements. With training you can learn to use your neural
Two small arrays about the size of pencil erasers
signals to
will be implanted through a flap in your skull
control
a
approximately 5x5 cm in size. The wires from
variety
of
the arrays will be attached to a connector that is
devices or
fixed to the skull where it can be connected to
computer
our computer system. You will likely spend up to
displays.
2 weeks in the hospital for post-surgical moniParticipants will learn to control
virtual environments.
toring.
about 1 week after surgery. You will also be
asked to return for follow-up visits to monitor
your recovery. The total duration of the study
will be up to 25 months.
University of Pittsburgh
Dept. of Physical Medicine & Rehabilitation
Human Rehabilitation and Neural
Engineering Lab (hRNEL)
If you may be interested in participating, please
contact Debbie Harrington, research coordinator
Phone: 412-383-1355
Email: harringtond2@upmc.edu
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