News: 2011
QuantaLife Droplet DigitalTM PCR Receives 2011 Frost
& Sullivan Award Innovation, QuantaLife, June 28, 2011
Based on recent analysis of the personalized medicine market, Frost & Sullivan recognizes
NIBIB grantee QuantaLife, Inc. with the 2011 North America Frost & Sullivan Award
for New Product Innovation for its Droplet Digital Polymerase Chain Reaction (ddPCR)
System. The QuantaLife ddPCR System introduces the next generation of PCR by providing
absolute quantification of nucleic acid molecules.
More...
Bioengineering Research Partnership Work Allows Paraplegic Man
to Stand, Move Legs: May 23, 2011
The NIBIB Rehabilitation Engineering program supports the development of next generation
medical rehabilitation devices and systems that presents a paradigm shift from the
current state of the art technology. In 2008, NIBIB awarded a 5-year Bioengineering
Research Partnership (BRP) grant to the University of California Los Angeles for
Dr. Reggie Edgerton and his multidisciplinary team to develop the next generation
high density electrode array technology for epidural stimulation of the spinal cord.
In this first-in-human study the investigators proposed to explore the possibility
of humans regaining standing and stepping functions (as observed previously in animals)
through a combination of epidural stimulation with motor training. In year 2 of
the award, the first implanted human subject is now able to stand and move his previously
paralyzed lower limbs.
Scientists funded in part by the National Institutes of Health report that after
intensive physical therapy and electrical stimulation to the spine, a man with a
paralyzing spinal cord injury has recovered the ability to stand and move paralyzed
muscles when the stimulator is active.
A car accident in 2006 left Rob Summers completely paralyzed from the chest down.
Summers, now 26 years old, is participating in a pilot trial that combines locomotor
training and epidural stimulation. The locomotor training involves being supported
over a treadmill, either in a harness or by hand rails, while a team of physical
therapists work with his legs to help him stand and step on the machine. During
epidural stimulation, electrical pulses are delivered to the surface of his spinal
cord, below the injury.
“While these results are obviously encouraging, we need to be cautious, and
there is much work to be done,” said V. Reggie Edgerton, Ph.D., a professor
of physiology at the University of California Los Angeles. Dr. Edgerton conducted
the new study in collaboration with Susan Harkema, Ph.D., the director of rehabilitation
research at the Kentucky Spinal Cord Injury Research Center at the University of
Louisville. The team published data on Summers’ improvement in The Lancet.*
The team’s novel approach to rehabilitation was developed through research
on animals, supported by NIH’s National Institute of Neurological Disorders
and Stroke (NINDS). This first-in-human study as well as a parallel development
of the new stimulator technology is supported by a NIH Bioengineering Research Partnership
from the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The
Christopher and Dana Reeve Foundation also contributed to the study.
Summers’ accident dislocated a segment of his spine between his neck and chest.
He lost most movement and sensation below the injury, including the ability to control
his legs. He began working with Dr. Edgerton in 2007, and received months of locomotor
training with no epidural stimulation. While he hung over the treadmill for hours
at a time, physical therapists moved his legs in stepping motions.
The locomotor training by itself did not improve Summers’ ability to stand
or walk. But he did improve after December 2009, when electrodes were surgically
implanted over the paralyzed area of his spinal cord near the bottom of his ribcage,
and used to deliver rhythmic electrical bursts during the locomotor training sessions.
During his efforts to stand on the treadmill, his supporting harness was gradually
lowered until he was able to stand and fully bear his own weight for up to four
minutes at a time. He is not able to walk on the treadmill. While standing with
the stimulator on, however, he can bend one leg at the knee, flex his ankle and
extend his big toe.
"This study is an example of the convergence of the physical, neurological
and clinical sciences to develop novel approaches that could improve the lives of
individuals with spinal cord injuries,” said Belinda Seto, Ph.D., deputy director
of NIBIB. “There is still much work to be done to optimize the multi-electrode
stimulator technology, including determining the most effective stimulation patterns,”
added Grace C.Y. Peng, Ph.D., the NIBIB program director who oversees the project.
The investigators do not know precisely how epidural stimulation works. The approach
emerged from research on basic spinal cord physiology, largely supported by NINDS.
When we decide to move, our brains send signals that travel through our spinal cords
and to our muscles. The feel of the movement, for example our feet hitting the ground
as we walk, is transmitted back to the spinal cord by sensory nerve cells –
and ultimately back to the brain. However, the spinal cord also contains local circuits
that are capable of producing and sensing movements even without the brain’s
control. The knee jerk reflex is a simple example from everyday life.
Dr. Edgerton’s research on animals with spinal cord injury has shown that
local circuits in the spinal cord can also drive more complex movements, such as
stepping. In a recent study on rats with spinal cord injury, Dr. Edgerton showed
that combining epidural stimulation with sensory input – feeling the motion
of a treadmill – helped the rats regain the ability to walk. The rats also
received drugs that mimic the effects of serotonin, a chemical messenger that excites
nerve cells in the spinal cord.
The serotonin-like drugs that were used in the rats are not suitable for human use
and will require further development, the researchers say.
Along with the animal studies, there were hints that people with spinal cord injuries
might respond to a similar combination of treadmill training and spine stimulation.
Locomotor training, without any epidural stimulation, is routinely used as a rehabilitative
technique for people with so-called incomplete spinal cord injuries, which means
they still have some ability to move and feel below the injury. Meanwhile, a form
of epidural stimulation is used to relieve pain for some patients.
While Summers retained some sensation below his injury, his legs were completely
paralyzed. This is the first time researchers have found that locomotor training
and epidural stimulation together can help someone with such a severe injury. It
is believed that the epidural stimulation and locomotor training have two distinct
roles. The stimulation appears to have a non-specific effect, switching on intact
circuits in the spinal cord. Meanwhile, the training relays specific information
about the body and its position, for example, whether the person is standing or
walking.
"These studies show that after a spinal cord injury, the sophisticated circuitry
of the spinal cord remains, ready to coordinate complex movements if it receives
the right commands," said Naomi Kleitman, Ph.D., a program director at the
National Institute of Neurological Disorders and Stroke (NINDS). "Harnessing
that potential has been the goal of decades of research to understand spinal cord
function and to find effective ways to restore that function after injury."
One mystery is that for Summers, the physical therapy and stimulation to the spinal
cord appeared to do something more than activate the local circuits in his spinal
cord. The treatment actually put the power of movement under his control. With the
stimulator turned on, he stood up when he wanted to stand, and he could move his
legs, feet and toes when asked. The researchers have two theories for how this happened.
One possibility is that the stimulation amplifies weak signals that manage to reach
the injured spinal cord from the brain, but are not strong enough to produce muscle
contractions on their own. Another possibility is that the stimulation helps nerve
cells in the cord grow and establish new connections.
Summers is the first of five individuals participating in this trial. The researchers
and NIH scientists caution that further study is required to confirm these early,
promising results and to understand exactly how the stimulation is working.
"We still have much to learn about how different people will respond to this
type of stimulation," said Dr. Kleitman. "Testing of more individuals
is needed, as every spinal cord injury and patient is different. Drugs that make
the spinal circuits more sensitive to the stimulation may be added to the therapy
in the future."
*Harkema S et al. "Effect of epidural stimulation of the lumbosacral spinal
cord on voluntary movement, standing, and assisted stepping after motor complete
paraplegia: a case study." The Lancet, published online May 20, 2011.
NIBIB (www.nibib.nih.gov), a component of NIH, is dedicated to improving
health by bridging the physical and biological sciences to develop and apply new
biomedical technologies.
NINDS (www.ninds.nih.gov)
is the nation’s leading funder of research on the brain and nervous system.
The NINDS mission is to reduce the burden of neurological disease – a burden
borne by every age group, by every segment of society, by people all over the world.
The National Institutes of Health (NIH) – The Nation’s Medical Research
Agency – includes 27 Institutes and Centers and is a component of the U.S.
Department of Health and Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases. For more information
about NIH and its programs, visit www.nih.gov.
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Last Updated On 05/30/2012