FDA Approves Clinical Trial of Auditory Brainstem Implant Procedure for Children in the U.S.

L.A.-based House Research Institute and Children’s Hospital Los Angeles announced today that the United States Food and Drug Administration (FDA) has given final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children. The trial is a surgical collaboration sponsored by the House Research Institute in partnership with Children’s Hospital Los Angeles and Vittorio Colletti, MD of the University of Verona Hospital, Verona, Italy.

The ABI was developed at the House Research Institute and is the world’s first successful prosthetic hearing device to stimulate neurons directly at the human brainstem, bypassing the inner ear and hearing nerve entirely. Since the procedure began, more than 1,000 adults worldwide have received the ABI, with surgeons at the House Clinic leading the way.

“This will be the first FDA-approved trial of its kind, and represents a major step forward to bring a sense of hearing to deaf children in the U.S. who are born without a hearing nerve or cochlea (hearing organ) and therefore are unable to benefit from hearing aids or cochlear implants,” said Neil Segil, Ph.D, executive vice president for research, House Research Institute. “Since its development at the House Research Institute in 1979 by Drs. William House and William Hitselberger, the ABI has been successful in providing a sense of sound to many adults in the U.S., however it has never been approved by the FDA for treating deafness in children. This study has the potential to expand the use of this remarkable device, which represents the only effective sensory prosthetic for direct brain stimulation in use today.”

The Pediatric ABI team includes physicians and researchers from the House Research Institute, including Eric Wilkinson, MD, Laurie Eisenberg, Ph.D., Robert Shannon, Ph.D.; Marc Schwartz, MD; Laurel Fisher, Ph.D.; Steve Otto, M.A., and Margaret Winter, M.S., as well as Children’s Hospital Los Angeles’ Mark Krieger, MD and Gordon McComb, MD; and Verona Hospital’s Vittorio Colletti, MD; Marco Carner, MD; and Liliana Colletti, Ph.D.

“We’re excited to have reached this milestone and look forward to being able to offer this amazing technology to children in the United States who currently have no other option for hearing rehabilitation,” said Eric Wilkinson, MD, co-principal investigator and lead physician for the clinical trial.

Will we ever… have cyborg brains?

For the first time in over 15 years, Cathy Hutchinson brought a coffee to her lips and smiled. Cathy had suffered from the paralysing effects of a stroke, but when neurosurgeons implanted tiny recording devices in her brain, she could use her thought patterns to guide a robot arm that delivered her hot drink. This week, it was reported that Jan Scheuermann, who is paralysed from the neck down, could grasp and move a variety of objects by controlling a robotic arm with her mind.

In both cases the implants convert brain signals into digital commands that a robotic device can follow. It’s a remarkable achievement, one that could transform the lives of people debilitated through illness.

Yet it’s still a far cry from the visions of man fused with machine, or cyborgs, that grace computer games or sci-fi. The dream is to create the type of brain augmentations we see in fiction that provide cyborgs with advantages or superhuman powers. But the ones being made in the lab only aim to restore lost functionality – whether it’s brain implants that restore limb control, or cochlear implants for hearing.

Creating implants that improve cognitive capabilities, such as an enhanced vision “gadget” that can be taken from a shelf and plugged into our brain, or implants that can restore or enhance brain function is understandably a much tougher task. But some research groups are being to make some inroads.

For instance, neuroscientists Matti Mintz from Tel Aviv University and Paul Verschure from Universitat Pompeu Fabra in Barcelona, Spain, are trying to develop an implantable chip that can restore lost movement through the ability to learn new motor functions, rather than regaining limb control. Verschure’s team has developed a mathematical model that mimics the flow of signals in the cerebellum, the region of the brain that plays an important role in movement control. The researchers programmed this model onto a circuit and connected it with electrodes to a rat’s brain. If they tried to teach the rat a conditioned motor reflex – to blink its eye when it sensed an air puff – while its cerebellum was “switched off” by being anaesthetised, it couldn’t respond. But when the team switched the chip on, this recorded the signal from the air puff, processed it, and sent electrical impulses to the rat’s motor neurons. The rat blinked, and the effect lasted even after it woke up.

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Woman With Quadriplegia Feeds Herself Chocolate Using Mind-Controlled Robot Arm

In a study published in the online version of The Lancet, the researchers described the brain-computer interface (BCI) technology and training programs that allowed Ms. Scheuermann, 53, of Whitehall Borough in Pittsburgh, Pa. to intentionally move an arm, turn and bend a wrist, and close a hand for the first time in nine years.

Less than a year after she told the research team, “I’m going to feed myself chocolate before this is over,” Ms. Scheuermann savored its taste and announced as they applauded her feat, “One small nibble for a woman, one giant bite for BCI.”

“This is a spectacular leap toward greater function and independence for people who are unable to move their own arms,” agreed senior investigator Andrew B. Schwartz, Ph.D., professor, Department of Neurobiology, Pitt School of Medicine. “This technology, which interprets brain signals to guide a robot arm, has enormous potential that we are continuing to explore. Our study has shown us that it is technically feasible to restore ability; the participants have told us that BCI gives them hope for the future.”

In 1996, Ms. Scheuermann was a 36-year-old mother of two young children, running a successful business planning parties with murder-mystery themes and living in California when one day she noticed her legs seemed to drag behind her. Within two years, her legs and arms progressively weakened to the point that she required a wheelchair, as well as an attendant to assist her with dressing, eating, bathing and other day-to-day activities. After returning home to Pittsburgh in 1998 for support from her extended family, she was diagnosed with spinocerebellar degeneration, in which the connections between the brain and muscles slowly, and inexplicably, deteriorate.

Experimental prosthetic leg lets amputees ‘feel’ each step

Human prosthetics have come a long way in recent decades. We’ve gone from simple plastic molds that vaguely resemble the original limb, to high-tech articulating devices that return most of a person’s mobility. Through all this progress, one nagging issue has continued to plague doctors — there’s still no way for a patient to feel a prosthetic. A new project out of UCLA might be on the path to changing that.

Having something that acts like a leg turns out to be only part of the puzzle, says UCLA grad student Zachary McKinney. When you take a step with your flesh-and-blood leg, the limb is constantly sending sensory signals back to the brain that inform you when it touches the ground, how much weight is on it, and how that weight is distributed among other things. Lacking that kind of feedback in a prosthetic causes long-term problems like uneven gait or strain on the remaining limb.

The UCLA project is not seeking to exactly replicate the sensation of having a real leg, but to provide a system that can relay the same information. The system currently consists of four sensors in the shoe of the prosthetic leg. As the subject takes a step, the system register how much pressure is on each sensor and sends that data to a small computer strapped to the user’s midsection.

The computer will analyze the data, and control the inflation of a series of small balloons on the thigh cuff. These 12 dime-sized silicon balloons are split into four sets of three, each one corresponding to one of the shoe sensors. The more pressure detected, the larger the balloons inflate. Current lag time is roughly 0.1 seconds, which is only a little slower than nerve impulses. For the patient, it is functionally instantaneous.

Results have been encouraging in initial testing. Nine subjects who had lost a leg were asked to walk across a 30-foot wide space with a normal prosthetic. After being given time to acclimate to the pressure-sensitive system, the test was run again. According to the researchers, seven distinct measurements of gait improved with the test rig.

Thought-controlled prosthesis is changing the lives of amputees

The world’s first implantable robotic arm controlled by thoughts is being developed by Chalmers researcher Max Ortiz Catalan. The first operations on patients will take place this winter.

“Our technology helps amputees to control an artificial limb, in much the same way as their own biological hand or arm, via the person’s own nerves and remaining muscles. This is a huge benefit for both the individual and to society”, says Max Ortiz Catalan, industrial doctoral student at Chalmers University of Technology in Sweden.

Ever since the 1960s, amputees have been able to use prostheses controlled by electrical impulses in the muscles. Unfortunately, however, the technology for controlling these prostheses has not evolved to any great extent since then. For example, very advanced electric hand prostheses are available, but their functionality is limited because they are difficult to control.

“All movements must by pre-programmed”, says Max Ortiz Catalan. “It’s like having a Ferrari without a steering wheel. Therefore, we have developed a new bidirectional interface with the human body, together with a natural and intuitive control system.”

Today’s standard socket prostheses, which are attached to the body using a socket tightly fitted on the amputated stump, are so uncomfortable and limiting that only 50 percent of arm amputees are willing to use one at all.
This research project is using the world-famous Brånemark titanium implant instead (OPRA Implant System), which anchors the prosthesis directly to the skeleton through what is known as osseointegration.

“Osseointegration is vital to our success. We are now using the technology to gain permanent access to the electrodes that we will attach directly to nerves and muscles”, says Max Ortiz Catalan.

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"I feel like the Terminator": One-armed man’s life transformed by advanced robot hand

A one-armed man’s life has been transformed by a robot hand so accurate it can grip an egg without cracking it.

Nigel Ackland’s advanced bionic limb has given him back the ability to do everyday tasks such as peeling vegetables, tying laces and typing.

The 53-year-old lost his right arm below the elbow after it was crushed in an industrial ­accident six years ago.

He struggled with NHS prosthetic parts and was selected to take part in a trial of the pioneering limb – controlled by him twitching muscles in his upper arm.

Nigel said: “I have been blown away by the robotic hand. I could sit and watch it all day. I feel like the ­Terminator.

"The fingers even move when I yawn and stretch.

“I am slowly becoming more at one with it. Tying a shoe lace and chopping a vegetable are now much easier.”

The former precious metals smelter said: “It has made a massive difference to my life and health. Losing a limb can take you into a dark place.”

Right-handed Nigel, who lives with wife Vanessa, 50, and son Conor, 19, in Royston, Cambridgeshire, was one of seven amputees around the world picked by British prosthetics firm RSLSteeper to try out the bebionic3 hand that costs between £8,000 and £12,000.

New metric to track prosthetic arm progress

A new validated and reliable measure of how well an adult amputee is able to perform everyday tasks with a prosthetic arm will help physical and occupational therapists, prosthetists, and doctors assess the progress that patients make during training with their new limb.

Amputees with a new prosthetic arm must learn how to use their device to perform everyday tasks that were once second nature. Taking off a shirt becomes a conscious, multistep effort: grasp the shirt, lift the shirt over the head, pull arms through the sleeves, place the shirt on the table, let go of the shirt.

In the best cases of treatment, patients work with teams of doctors, prosthetists, and therapists to learn how their new limbs can help them regain function and quality of life. But clinicians have had few tools to assess whether that crucial teaching/learning process is going well, because of a lack of standardized measurements to use with adults with upper limb amputations. To change that, a research team has unveiled a new index that clinicians can use to assess their patients’ progress. They describe the Activities Measure for Upper Limb Amputees (the AM-ULA) in an article published online Oct. 19 in the Archives of Physical Medicine and Rehabilitation.

New hope for the blind from neuroscientists?

Scientists in the Texas Medical Center believe that there may be a way to use mental images to help some of the estimated 39 million people worldwide who are blind.

Scientists in the laboratories of Michael Beauchamp, Ph.D., an associate professor of neurobiology and anatomy at the The University of Texas Health Science Center at Houston (UTHealth) Medical School, and Daniel Yoshor, M.D., an associate professor of neurosurgery and neuroscience at Baylor College of Medicine, have discovered a neural mechanism for conscious perception that could use the brain’s image-generating ability.

“While much work remains to be done, the possibilities are exciting,” said Beauchamp, the study’s lead author. “If successful, we would in essence bypass eyes that no longer work and stimulate the brain to generate mental images. This type of device is known as a visual prosthetic.”

UM Researchers Create Device to Help Stutterers

Drawing on one another’s expertise, a trio of University of Mississippi faculty members from different areas of campus has created a patent-pending device that could change the lives of people who stutter.

Paul Goggans, an electrical engineering professor, developed the prosthetic device, about the size of a cell phone, with Greg Snyder, associate professor of communications sciences and disorders, and Dwight Waddell, associate professor of health, exercise science and recreation management. The friends began working on the device after Snyder, himself a lifelong stutterer, demonstrated how he could speak much more fluently simply by feeling his throat while he and Waddell chatted over coffee.

“By feeling my throat vibrate when I speak, I get tactile speech feedback, which significantly reduces my stuttering,” Snyder said. “Dwight immediately understood my application of speech feedback and neural circuitry, and he then approached Paul, who agreed to make the device development a senior-level design project in his class.”

Since that time, the team has been focused on supporting and empowering the stuttering community by fighting social stigma and challenging the normal remedies associated with stuttering.
“Our device is portable, battery-powered and easy to use,” said Goggans, professor of electrical engineering and lead partner in the instrument’s design and fabrication. “These are important attributes because other behavioral treatments for stuttering are more intense; they require too much concentration and are exhausting.”

A prototype of the device was presented Tuesday (Oct. 16) as a “Hot Topic” at the 2012 Society of Neuroscience conference in New Orleans. The paper is among 150 selected from thousands of submissions.