11 august 2017.
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Exclusive: Woman Can Move Again After a Breakthrough Stroke Treatment
Aug 10, 2017
TIME Health
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The first person to receive deep brain stimulation (DBS) for stroke recovery is performing far better than her doctors anticipated.
Two
years ago, J udy Slater, a 59 year old in Pulaski, Pennsylvania, was
getting out of bed when she had a severe stroke. She fell down and
couldn’t get back up; the stroke had left her entire left side
paralyzed.
With
time, Slater was able to regain her ability to walk, but her left arm
remained almost entirely immobile, hanging against her side with her
elbow stuck tightly at 90 degrees. Her hands and fingers had curled up,
and she couldn’t extend them on her own. “I depended so much on my
family,” says Slater, who lives with her husband and daughter.
Slater’s
experience is not unique. In the United States, stroke is the leading
cause of serious long-term disability among Americans, and about half of
the 800,000 Americans who have a stroke every year end up disabled.
With physical therapy, people can regain some motor function, but more
than half of all people with stroke will continue to have severe
movement impairments.
After
the stroke, Slater couldn’t bathe or cook on her own, and she longed
for her former independence. That’s why she agreed to become the first
person in the world to receive deep brain stimulation (DBS) for stroke
recovery: a procedure in which electrodes are implanted in the brain to
provide small electric pulses. She is part of a new clinical trial at
the Cleveland Clinic aimed at helping people disabled by stroke regain
control of their movements.
A medical first
“Despite
advances in physical therapy and acute treatment of stroke, there are
still too many people who live with longterm disabilities, and new
technologies are needed,” says trial leader Dr. Andre Machado, chairman
of the Cleveland Clinic Neurological Institute.
Slater
is the first person to receive the treatment. Machado and his team
spent more than a decade testing DBS for stroke recovery in animals, and
DBS has been used to treat tremors associated with Parkinson’s disease,
but in that scenario, doctors are trying to get rid of tremors. In the
case of stroke, Machado and his team are trying to make movement come
back—a goal that's considered harder to pull off.
In
December 2016, Slater's skull was opened and doctor's surgically
implanted electrodes in the area of her brain called the cerebellum. The
electrodes provide small pulses that target damaged areas of the brain
to help recover movement. The electrodes are attached to a wire that
connects them to a small battery pack doctors surgically embedded under
the skin in her chest. After she recovered from the initial surgery,
Slater started physical therapy, and soon after that, her doctors turned
on the device.
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Four
months after the electrodes were turned on, Slater is doing better than
investigators expected. “Judy is performing exceptionally well,” says
Machado. “Since we’ve turned on the device, we’ve seen an acceleration
in her recovery, and we have not yet seen the limit of her gains.”
People
with severe impairments from stroke can improve with physical therapy
alone, but typically the gains are small and then plateau. Machado had
originally hoped that Slater would experience improved movement beyond
what was expected from physical therapy (DBS is not intended to replace
physical therapy, but to make it work better). Machado expected the
effects of DBS to eventually reach a similar plateau within about four
months, at which point his team would measure how much the procedure
contributed to her overall improvement.
But Slater has yet to stop improving.
“Week
by week and month by month, we see improvements,” says Machado. “There
is no flattening or tipping point. No one can predict where that point
will be.”
Not
only can Slater open up her left hand, but she can also move her wrist
and elbow. She can open her purse, reach into her bag and grab what she
needs. She can get dressed and do the dishes. “I am so excited I can
move my fingers and my hand, and reach in front of me and to the side,”
says Slater. "I can cook, cut vegetables and get dinner ready. It’s
still a little bit hard, but I can do it.”
“What
excites me is that we have reduced her dependence on other people,"
says Machado. "She has exceeded my expectations, and this gives us
courage to continue.”
An ethical dilemma
Slater’s
case has been inspiring and an encouraging proof of concept study. But
her results have put Machado in an ethical quandary. The study protocol
states that Slater’s stimulation should be turned off now that she has
used it for four months. That’s largely because no one—not Machado or
the other doctors who advised his research team—thought she would
improve beyond that time frame.
From
a scientific standpoint, researchers including Machado want to turn off
the device so they can learn whether a person keeps or loses the
improvements they made with the brain stimulation. Scientists need to
discover whether DBS for stroke is something a person uses for a few
months, or if it’s a lifelong implant.
But
Machado says he can’t bring himself to turn off Slater’s device—not
yet, at least. "Judy took a risk by becoming the first person ever to
have this surgery done," he says. "Imagine you are in my shoes. Would
you have the courage to turn it off? I’m an investigator and a
physician, and the physician side of me wins—I will continue to treat
her. No one has the heart to stop it.”
For
now, Slater will continue her physical therapy with the device turned
on, and Machado will work with the U.S. Food and Drug Administration—the
agency that would eventually review the device for possible market
approval—to change the study protocol. Cleveland Clinic has already
enrolled the second patient into the clinical trial and implanted them
with the electrodes; researchers will turn the device on after the
patient recovers. They don't plan to stop there: Researchers are
currently screening more people to potentially enter the trial.
Slater
says she is pleased to keep working with the device. “I’ve been
thinking about what happens if they turn it off,” she says. “I don’t
want to go back and start over where I was."
"I am happy I did it," she adds. "I still have a way to go, but I am going to get there.”
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