Neuron-fired device would aid paralyzed people, state firm says

[Max]

Neuron-fired device would aid paralyzed people, state firm says
By Jeffrey Krasner, Globe Staff, 11/6/2003

A Foxborough company is about to ask federal regulators for permission to start testing a device that would enable paralyzed people to control computers directly with their brains or possibly help them move their limbs.

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Cyberkinetics Inc. will present data at a neurology conference in New Orleans this weekend showing how it developed its BrainGate device after using it in animal trials. It plans to file a research request with the US Food and Drug Administration by the end of the year.

Initially, the device, implanted into the brains of paralyzed people, will help them control a cursor on a screen or play video games. But researchers at Cyberkinetics and several universities believe the technology could one day enable paralyzed people to type, control lights and heating controls, maneuver wheelchairs, or even manipulate robotic arms. Some think such efforts to capture brain impulses could enable such patients to move their arms and legs, which are immobilized because the brain's commands are blocked, such as when the spinal cord is severed.

"Testing these implants in humans is the next step," said Eberhard E. Fetz, professor at the Department of Physiology and Biophysics at the University of Washington, who has been experimenting with brain-signal devices since the late 1960s. "Within a decade, we'll see these being used regularly to control prosthetic devices or activate a patient's own muscles."

Boston University Medical Center is one hospital with spinal cord injury expertise that might participate in the trial, according to Timothy R. Surgenor, Cyberkinetics' president and chief executive. He said the initial trial will involve about five severely paralyzed patients who are unable to use their hands. The study will first test the safety of the implant and also seek to replicate the results achieved with monkeys.

Though there is a lot of research on devices that connect brains to computers, there are still relatively few companies active in what could be a huge new market for medical devices. Surgenor said there are about 200,000 paralyzed people in the United States, including about 40,000 quadriplegics.

"There may be a lot of things we can do to help people overcome disabilities," said Mark Carthy, a general partner at Oxford Bioscience Partners, a venture capital firm that has invested in Cyberkinetics. "In the long run we hope to come out with devices for people who have neurodegenerative diseases," such as ALS, known as Lou Gehrig's Disease, and elderly people who have lost certain functions but have active brains.

Researchers at Duke University last month generated tremendous excitement when they showed a brain implant that enabled monkeys to manipulate a robotic arm with their thoughts. In those experiments, monkeys had networks of fine wires implanted in their brains. They were taught how to move the robotic arm and grasp with the robotic hand using a joystick, like those used to control computer games.

A computer analyzed the brain waves, matching certain patterns with particular motions. Then, the joystick was removed, and the monkeys were able to control the robot arm using "mental intentions."

While several researchers have experimented with devices linking human brains and computers, few have done so in the context of a clinical trial -- a government-monitored series of experiments that can lead to government approval to sell the device.

Cyberkinetics was founded in June 2001 by John P. Donoghue, chairman of the Department of Neuroscience at Brown University in Providence. Last year, the firm demonstrated results similar to those at Duke; monkeys playing a video game with a joystick were able to continue playing moving the cursor with their thoughts.

Sunday, at the Society for Neuroscience's annual meeting in New Orleans, Cyberkinetics will spell out how it has improved the device used in those experiments to make it ready for tests in humans and will outline its plans for the initial clinical trial.

The BrainGate may sound like science fiction familiar to fans of "Robocop" movies, and it could look like it, too. The device is 4 millimeters square, considerably smaller than a dime. It contains 100 tiny wires, a technology the company acquired when it merged last year with Bionic Technologies LLC of Salt Lake City. After making a hole in the patient's skull, the wire array is precisely punched into the surface of the brain.

"There's an inserter, a spring-loaded thing, that taps it into the brain with just the right amount of force," said Surgenor in a telephone interview. The wire array will be positioned over one of the areas of the brain known to control motor activity.

After the implant, the only thing visible on the patient's head will be a connector, not unlike those in the back of a VCR. The computer cable that attaches to it looks a lot like the coaxial cable that delivers cable television, right down to the nut that will tighten it in the socket.

The wires detect when brain cells, or neurons, are fired.

"We'd expect to get signals from 20 to 100 neurons from the array," Surgenor said. "It turns out that when you have more than 20 neurons, you have enough information to decode where in space somebody wants to put their hand."

Surgenor predicted the firm would file to the FDA its application, called an Investigational Device Exemption, by the end of the year. If the plan is approved by regulators, the company hopes to begin the trial early next year and complete the experiment by the end of the year.

Cyberkinetics raised $4.3 million in August, bringing the total investment in the start-up to $9.3 million. Carthy, of Oxford Bioscience, said that is sufficient to fund the company for two years.

"At the end of that, we'd have a lot of data from the clinical trials and we'd be able to outline our commercial stratagem," he said.

Jeffrey Krasner can be reached at krasner@globe.com. Carey Goldberg of the Globe staff contributed to this report.

© Copyright 2003 Globe Newspaper Company.
http://www.boston.com/business/techn...brain_implant/

[antiquity]

Author Topic: Â* Approval sought to test brain implant
jimnms

Member posted Nov 07, 2003 10:56 PM Â*
------------------------------------------------------------------------
Click here for the original story.

Neuron-fired device would aid paralyzed people, state firm says

By Jeffrey Krasner, Globe Staff, 11/6/2003

A Foxborough company is about to ask federal regulators for permission to start testing a device that would enable paralyzed people to control computers directly with their brains or possibly help them move their limbs.

Cyberkinetics Inc. will present data at a neurology conference in New Orleans this weekend showing how it developed its BrainGate device after using it in animal trials. It plans to file a research request with the US Food and Drug Administration by the end of the year.

Initially, the device, implanted into the brains of paralyzed people, will help them control a cursor on a screen or play video games. But researchers at Cyberkinetics and several universities believe the technology could one day enable paralyzed people to type, control lights and heating controls, maneuver wheelchairs, or even manipulate robotic arms. Some think such efforts to capture brain impulses could enable such patients to move their arms and legs, which are immobilized because the brain's commands are blocked, such as when the spinal cord is severed.

"Testing these implants in humans is the next step," said Eberhard E. Fetz, professor at the Department of Physiology and Biophysics at the University of Washington, who has been experimenting with brain-signal devices since the late 1960s. "Within a decade, we'll see these being used regularly to control prosthetic devices or activate a patient's own muscles."

Boston University Medical Center is one hospital with spinal cord injury expertise that might participate in the trial, according to Timothy R. Surgenor, Cyberkinetics' president and chief executive. He said the initial trial will involve about five severely paralyzed patients who are unable to use their hands. The study will first test the safety of the implant and also seek to replicate the results achieved with monkeys.

Though there is a lot of research on devices that connect brains to computers, there are still relatively few companies active in what could be a huge new market for medical devices. Surgenor said there are about 200,000 paralyzed people in the United States, including about 40,000 quadriplegics.

"There may be a lot of things we can do to help people overcome disabilities," said Mark Carthy, a general partner at Oxford Bioscience Partners, a venture capital firm that has invested in Cyberkinetics. "In the long run we hope to come out with devices for people who have neurodegenerative diseases," such as ALS, known as Lou Gehrig's Disease, and elderly people who have lost certain functions but have active brains.

Researchers at Duke University last month generated tremendous excitement when they showed a brain implant that enabled monkeys to manipulate a robotic arm with their thoughts. In those experiments, monkeys had networks of fine wires implanted in their brains. They were taught how to move the robotic arm and grasp with the robotic hand using a joystick, like those used to control computer games.

A computer analyzed the brain waves, matching certain patterns with particular motions. Then, the joystick was removed, and the monkeys were able to control the robot arm using "mental intentions."

While several researchers have experimented with devices linking human brains and computers, few have done so in the context of a clinical trial -- a government-monitored series of experiments that can lead to government approval to sell the device.

Cyberkinetics was founded in June 2001 by John P. Donoghue, chairman of the Department of Neuroscience at Brown University in Providence. Last year, the firm demonstrated results similar to those at Duke; monkeys playing a video game with a joystick were able to continue playing moving the cursor with their thoughts.

Sunday, at the Society for Neuroscience's annual meeting in New Orleans, Cyberkinetics will spell out how it has improved the device used in those experiments to make it ready for tests in humans and will outline its plans for the initial clinical trial.

The BrainGate may sound like science fiction familiar to fans of "Robocop" movies, and it could look like it, too. The device is 4 millimeters square, considerably smaller than a dime. It contains 100 tiny wires, a technology the company acquired when it merged last year with Bionic Technologies LLC of Salt Lake City. After making a hole in the patient's skull, the wire array is precisely punched into the surface of the brain.

"There's an inserter, a spring-loaded thing, that taps it into the brain with just the right amount of force," said Surgenor in a telephone interview. The wire array will be positioned over one of the areas of the brain known to control motor activity.

After the implant, the only thing visible on the patient's head will be a connector, not unlike those in the back of a VCR. The computer cable that attaches to it looks a lot like the coaxial cable that delivers cable television, right down to the nut that will tighten it in the socket.

The wires detect when brain cells, or neurons, are fired.

"We'd expect to get signals from 20 to 100 neurons from the array," Surgenor said. "It turns out that when you have more than 20 neurons, you have enough information to decode where in space somebody wants to put their hand."

Surgenor predicted the firm would file to the FDA its application, called an Investigational Device Exemption, by the end of the year. If the plan is approved by regulators, the company hopes to begin the trial early next year and complete the experiment by the end of the year.

Cyberkinetics raised $4.3 million in August, bringing the total investment in the start-up to $9.3 million. Carthy, of Oxford Bioscience, said that is sufficient to fund the company for two years.

"At the end of that, we'd have a lot of data from the clinical trials and we'd be able to outline our commercial stratagem," he said.

_____
Learn from the mistakes of others, you won't live long enough to make all of them yourself.
------------------------------------------------------------------------
Posts: 468Â*|Â*From: MississippiÂ*|Â*Registered: 01-01-03

[Max]

Clinical Trial Participant with Quadriplegia Uses His Own Thoughts to Control a Computer and a Prosthetic Hand
(I-Newswire) - FOXBOROUGH, Mass.--Dec. 2, 2005--Cyberkinetics Neurotechnology Systems, Inc. ( OTCBB: CYKN ) ( Cyberkinetics ) announced today that John Donoghue, Ph.D., Founder and Chief Scientific Officer of Cyberkinetics and Chairman of the Department of Neuroscience at Brown University was interviewed in the Thursday's segment of the Today Show entitled "Mind-moving Machines to Help the Disabled." Hosted by Katie Couric, the program also featured Matthew Nagle, the first participant in Cyberkinetics' ongoing clinical trial of its BrainGate( TM ) Neural Interface System ( BrainGate ). The segment was the fourth program in the Today Show's weeklong series called "Saving Your Life: Modern Medical Miracles." The segment was taped previously during the actual clinical trial and at the Company's headquarters in Foxborough, Massachusetts.

Matthew Nagle, the first participant in Cyberkinetics' ongoing clinical trial of the BrainGate System, demonstrated his ability to use his own thoughts to control a computer and command the prosthetic hand on a table beside him to open and close. Mr. Nagle is currently paralyzed from the neck down due to an injury four years ago that severed his spinal cord.

On the Today Show, Dr. Donoghue discussed the scientific and practical implications of Cyberkinetics' breakthrough brain interface technology, including Cyberkinetics' progress toward development of the BrainGate System technology to enable those with quadriplegia to perform a variety of everyday living tasks that would, if the Company is successful, enable them to become more self-sufficient and independent.

Commenting on the excitement surrounding Cyberkinetics' BrainGate technology, Dr. Donoghue continued, "The preliminary success we have seen with Matthew and the second participant in the trial support our continued development of the BrainGate System as we move closer to our ultimate objective: the creation of a thought-controllable operating system for people with severe paralysis that enables them, eventually we hope, to move their own limbs."

About the BrainGate( TM ) System

The BrainGate Neural Interface System is a proprietary, investigational brain-computer interface ( BCI ) that consists of an internal sensor to detect brain cell activity and external processors that convert these brain signals into a computer-mediated output under the person's own control. The sensor is a tiny silicon chip about the size of a baby aspirin with one hundred electrodes, each thinner than a human hair, that can detect the electrical activity of neurons. The sensor is implanted on the surface of the area of the brain responsible for movement, the motor cortex. A small wire connects the sensor to a pedestal that is placed on the skull, extending through the scalp. An external cable connects the pedestal to a cart containing computers, signal processors and monitors that enable the study operators to determine how well study participants can control devices driven by their neural output - that is, by thought alone. The ultimate goal of the BrainGate System development program is to create a safe, effective and unobtrusive universal operating system that will enable those with motor impairments resulting from a variety of causes to quickly and reliably control a wide range of devices, including computers, assistive technologies and medical devices, simply by using their thoughts.

A pilot study of the BrainGate System is currently underway in those with severe paralysis resulting from spinal cord injury ( SCI ), muscular dystrophy, or with "locked-in" syndrome ( tetraplegia and the inability to speak ) secondary to stroke. Two participants have received BrainGate implants in this study, one of whom has recently completed one year in the trial. Previously published results from this study of the BrainGate System have demonstrated that a person with severe paralysis can control a computer cursor in order to operate external devices, as well as to operate a prosthetic hand. Enrollment for the BrainGate SCI study is currently open through the Spaulding Rehabilitation Hospital in Boston, Massachusetts, the Rehabilitation Institute of Chicago in Illinois, and the Sargent Rehabilitation Center in Providence, Rhode Island.

A second pilot study is currently enrolling individuals with ALS ( Amyotrophic Lateral Sclerosis or Lou Gehrig's disease ) or another motor neuron disease ( MND ) at the Massachusetts General Hospital in Boston, Massachusetts. The study is open to participants that live within a two-hour drive of Boston, Massachusetts, and that meet the study's selection criteria. The two primary goals of the pilot clinical study are to characterize the safety profile of the device and to evaluate the quality, type, and usefulness of neural output control that participants can achieve by using their thoughts. A long-term goal of this research is to develop a system that can be used by those with ALS or other motor neuron diseases without the assistance of a technician.


http://i-newswire.com/pr51345.html

[Max]

The next big bang: Man meets machine



By Staff, TheDeal.com
http://news.com.com/The+next+big+bang+Man+meets+machine/2100-1008_3-6076627.html

Story last modified Mon May 29 08:45:11 PDT 2006

In science-fiction fantasies, the melding of organic matter and digital technology usually takes human form, from Steve Austin's six-million-dollar bionics to the replicants running amok in "Blade Runner" to the Terminator. Yet research on multiple fronts in digital technology, biotechnology and nanotechnology may, over the next half century, alter the way we think about computers and information, and our relationship to them. With these changes, bionic body parts won't seem so far-fetched as we increasingly develop ways to integrate high-tech materials into our mortal flesh.
And the reverse is true as well. Researchers are now looking to biological materials such as bacteria, viruses, proteins and DNA to replace mechanical parts in computers. And as the age of genetic engineering matures, scientists are already borrowing techniques from software developers to build libraries of genetic information.
All of these overlapping strands of scientific inquiry are known colloquially as "BANG," which stands for bits, atoms, neurons and genes. "All these things are converging because biology, nanotech and organic chemistry are running together," says Mark Bunger, an analyst with Lux Research. "The boundaries are really getting sketchy."
Some of the advances are in the earliest phases of research and won't produce actual products for years, if at all. But some of these concepts have quietly been with us for years. Sixty thousand people worldwide, for example, have cochlear implants, surgically implanted devices that do electronically what the ear can no longer do naturally--transform vibrations into signals the brain interprets as sound. Prosthetic limbs are increasing in sophistication. And now, tech applications are making their way into other parts of the human body.
Mind control
One of the best examples from this new world where man meets machine, and biology and digital technology come together with stunning results, occurred in an unassuming young man from the suburbs south of Boston.
Matthew Nagle was a normal American guy who played football in high school and loved his local teams. A few years after graduation, he was looking into a job with the U.S. Postal Service--until a July night in 2001 when he was knifed in the neck during a fight at the beach. The blow severed his spinal cord and left him paralyzed from the neck down.
Young, optimistic and otherwise healthy, Nagle at age 24 volunteered to be a human guinea pig--the first recipient of an implant developed at Brown University. Nagle spent a year connected to the BrainGate system, with a chip the size of a lentil resting on a part of his brain that controls motor functions. The chip, 16 millimeters square with 100 gold spikes on it, was sensitive enough to pick up Matt's brain activity when he thought about movement.
The chip was connected to a cable that emerged from the top of Matt's skull and into a contraption that resembled devices from "The Matrix" movies. In those films, Keanu Reeves is hooked up to a computer from a box in the back of his neck, which downloads intelligence into him. ("Whoa," he says upon waking. "I know kung fu.") Nagle's connection went the other way; the implant uploaded brain signals into a software program that, with some tweaking, learned to interpret what they meant.
Here's how it works: When the patient's neurons fire, electrodes pick up the electrical activity; when the neurons are firing well, they generate electrical "spikes." The software reads these spikes as "movement intention."
Elizabeth Razee, a spokeswoman for Cyberkinetics Neurotechnology Systems, which ran the BrainGate trial, describes the process. "When you want to move your arm up and to the left, for example, the neurons on your motor cortex actually fire in a specific sequence. The computer software reads that intention and translates it into cursor action on the screen 'up and to the left.'"
Nagle quickly learned how to control an on-screen cursor and other visual interfaces, such as a "Pong" paddle, with his mind. The footage is surreal. Nagle sits immobile in his wheelchair, speaking with the aid of a ventilator and playing "Pong" or "Tetris" or changing channels on a TV.
Nagle's year with the BrainGate ended last fall, and the implant has now been removed, but Cyberkinetics provided archive video and interviews with Nagle. "It's kind of a trip to think that my brain signals were controlling a mouse," he says. "Who knows, in two or three years, they might put it back in. I'd do it all over again. It did a lot of good."
Lou Gehrig's disease
Cyberkinetics now has another spinal cord patient using BrainGate, but unlike Nagle the new patient has chosen to remain anonymous. The company says the next step is to test the system with patients suffering from amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig's disease, named after the New York Yankee who retired in 1939 after his diagnosis and died two years later.

http://news.com.com/2102-1008_3-6076627.html

[Chris Chappell]

Will technology and its applications for our needs outpace biology and its implementation?

Without biologically based clinical trials I think that technology will be our first and best option.

I guess that time will tell.

[Max]

Brain-to-comp links yield neurotherapies

Posted : 01 Jun 2006 Print Version E-mail this to a colleague Send inquiry

Technology that can establish a direct connection between human thought and computer operations has been a visionary proposition for decades. Now, thanks to the entrepreneurial efforts of some longtime researchers in the field, techniques that might help restore neurologically-impaired people's command over their environment are nearing commercialization.
One effort is offering medical researchers a new window into the brain, allowing them to acquire specific neural activity with electronic precision so that the relation between thought and motor action in the body can be decoded. The technology is being marketed as the Braingate neural contact system by Cyberkinetics Neurotechnology Systems Inc. But company founder John Donoghue, chairman of the Department of Neuroscience at Brown University, is looking well beyond diagnostics, positioning the company for a frontal attack on one of the most intractable problems in medicine: restoring function to people with damaged nervous systems.
Toward that end, Cyberkinetics recently acquired Andara Life Sciences Inc., whose founder, Purdue neuroscientist Richard Borgens, has developed an electronic method for stimulating neuron growth. Cyberkinetics has also established an R&D agreement with a group at Case Western Reserve University that has developed an implantable electrode system for stimulating muscle movement. The FDA has already approved the Case Western system for use.
The techniques behind these initiatives are anything but overnight phenomena. Indeed, most of the work began in the 1970s, when medical researchers first began to make electrical contacts with neurons, analyzing the response with signal processors. Gradually, knowledge of how neurons communicate and process information has been acquired, even as electronic systems have grown more sophisticated. Now the fields are coming together to realize the "bionic man"—an idea that captured the public's imagination in the '70s even as researchers were working the problem in the lab.
Parallel processor
Early research, Donoghue said, was "heavily involved in the fundamental properties of movement and how the brain controls movement—both to understand normal movement and to understand what happens to movement when something goes wrong with the nervous system." Medical researchers began to realize that the brain is a parallel processor. Thus, merely contacting single neurons to analyze their behavior would never unlock the secrets of brain/body control systems.
"A lot of people were working on the problem of how neurons in the brain code for movement. We needed a particular tool, called an electrode array, that could record lots of neurons," he recalled. "We worked hard over the years to develop a method to record lots of neurons and to make sense out of the language of neurons, and as we did that, it became clear to us that what we were developing was a revolutionary sensor in the brain—and that we could understand the language of neurons in the brain." It dawned on researchers that the ability to contact the brain and decode its neural signals might lead to techniques to let people with irreparable nerve damage directly control mechanical devices in their environment via computers. A relatively simple strategy would be to show that someone could control a cursor on a computer screen through the same cognitive mechanisms that we use to control our limbs. Once that feat had been achieved, modern wired or wireless embedded control systems could be activated to give someone with no motor control over their body quite a bit of control over their environment.


http://www.eetasia.com/ART_880041995...9200606_no.HTM

[Curt Leatherbee]

I have spoken directly with Reps from the company, nearly got a job working there, and this is probabley still decades away.

[artsyguy1954]

Originally Posted by Curt Leatherbee

I have spoken directly with Reps from the company, nearly got a job working there, and this is probabley still decades away.

I knew it.

[Tufelhunden]

Originally Posted by Chris Chappell

Will technology and its applications for our needs outpace biology and its implementation?

I really, sincerely hope not.

[Tufelhunden]

I tend to think this would be more applicable to individuals who have lost entire appendages. In most cases of SCI, the ONLY difference between us and the AB'd population is millimeters of a very particular tissue which stubbornly refuses to get its shit together and repair itself.