Cyberkinetics, Case to develop system to help restore extremity function

10/13/05

Development program with Cleveland FES Center funded by $4.4 million grant from NIH center

FOXBOROUGH, MA and CLEVELAND, OH October 13, 2005 Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN) (Cyberkinetics), Case Western Reserve University (Case) and the Cleveland FES (Functional Electrical Stimulation) Center (FES Center) today announced that they have been awarded a five-year, $4.4 million contract from the National Center for Medical Rehabilitation Research (NCMRR), a component of the National Institute of Child Health and Human Development (NICHD). According to the contract, Cyberkinetics will receive up to $2.3 million of the total award over the five-year period covered by the agreement.

The contract provides Cyberkinetics, Case and the FES Center with financial resources to support the joint development of a neuroprosthetic system capable of restoring partial arm and hand function to individuals with extensive paralysis due to high cervical spinal cord injury (SCI). The joint project will combine limb movement technology developed at Case and the FES Center with brain-interface technology developed at Cyberkinetics. The proposed neuroprosthetic system would offer human users an advanced system incorporating Cyberkinetics' BrainGateTM Neural Interface System (BrainGate System) to sense intended movement and generate command signals. The command signals would drive a hybrid FES-orthosis, an orthotic device for the upper limbs, designed to provide the user with thought-controlled arm and hand movement through the use of the patient's own muscles. The purpose of the device will be, ultimately, to restore voluntary control of paralyzed muscles.

"We are very excited to combine Cyberkinetics' unique expertise in human brain interfaces with the FES Center's unique expertise in using functional electrical stimulation to restore meaningful arm and hand function to individuals with complete arm paralysis," stated Robert Kirsch, Ph.D., Principal Investigator, Case Western University and the Cleveland FES Center.

"The ultimate goal of the BrainGateTM System is to provide an operating system that enables people with paralysis to move their own limbs simply by thinking," said John Donoghue, Ph.D., Chief Scientific Officer of Cyberkinetics. "This contract is a critical first step toward achieving our goal. We are extremely enthusiastic to be working with Case and the FES Center's world-class team of investigators to advance restorative rehabilitation for paralyzed people. In addition, we are gratified that the NICHD has provided us the opportunity to develop our BrainGateTM technology that has the potential to improve the lives of those with severe paralysis."

"We are honored to be working with a premier academic institution and with renowned researchers and physicians to develop technology that aims to improve the lives of those with spinal cord injuries," added Timothy R. Surgenor, President and Chief Executive Officer of Cyberkinetics. "As a result of being awarded this contract, Cyberkinetics now has expanded resources to further develop applications of the BrainGateTM System with the goal of enabling those with severe motor impairments to control their own limbs."

The collaboration between Cyberkinetics and Case pairs two state-of-the-art technologies. Cyberkinetics is the first and, to date, the only group to obtain FDA-approval for a pilot trial in humans using an implantable multichannel, intracortical microelectrode array. The ongoing pilot study aims to test the ability of an individual with high cervical SCI to control computers and other external devices with signals obtained from the motor cortex. Cyberkinetics is currently reviewing data from two participants implanted with the BrainGate System. The Cleveland FES Center at Case Western has a track record in the implementation of upper-extremity FES systems covering more than 25 years with more than 300 users. Investigators from both teams have extensive experience in decoding cortical signals into multidimensional movement commands for real-time control of FES systems, computers, and robotic devices in experiments using monkeys. Together, the team has the potential to advance cortical interfaces into the world of restorative rehabilitation as a "brain-body interface" (BBI).

About the BrainGateTM System
The BrainGate Neural Interface System is a proprietary brain-computer interface (BCI). BrainGate is an investigational device currently in pilot clinical trials 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, and in this implementation (project) the muscles of a person with paralysis, simply by using their thoughts.

Cyberkinetics is currently conducting two pilot clinical trials of the BrainGateTM System. In its first pilot clinical trial currently underway, clinical researchers are testing the safety and feasibility of the BrainGate 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. Previously published results from this study of the BrainGate System have demonstrated that a person with severe paralysis may be able to control a computer cursor in order to operate external devices, as well as to operate a prosthetic hand. In a second pilot trial, researchers are testing the BrainGate System in those with ALS (amyotrophic lateral sclerosis or Lou Gehrig's disease) and other motor neuron diseases. The study is being conducted at Massachusetts General Hospital (MGH).

About FES (Functional Electrical Stimulation)
FES is a method of applying low level electrical currents to the body to restore or improve function. A heart pacemaker is one example of an FES System. Another example of an FES System is one which employs an electrical current to restore movement by initiating muscle contractions in paralyzed extremities. The main components of an FES system are the electrodes, the stimulator, and sensors or switches. When FES is being used to move muscles, current pulses in the electrodes cause the weakened or paralyzed muscles to contract. Electrodes may be placed on the surface of the skin or they may be implanted under the skin. The stimulator controls the strength and timing of the low-level pulses that flow to the electrodes. The sensors or switches control the starting and stopping of the pulses supplied by the stimulator. To be truly practical, an FES system needs to correct for changes in the environment and day-to-day changes in the user's body via a feedback method that can adjust the stimulation so that it accomplishes the desired movement. Some FES systems are currently available to consumers, others are undergoing clinical evaluation, and many are still in development. In the future, neuroprosthetic devices such as the one being developed under this contract will combine FES technology with direct control by the human brain to offer a fully functioning closed loop limb movement system for persons with upper extremity paralysis.

About the Cleveland FES Center
The Cleveland Functional Electrical Stimulation (FES) Center, a consortium of the Department of Veterans Affairs, Case Western Reserve University, and MetroHealth Medical Center, provides innovative options for restoring neurological health and function by developing advanced technologies and integrating them into clinical care. The Center's focus is to improve people's lives by supporting fundamental research in the neuro-muscular sciences, developing new technologies and methods, performing clinical evaluation and feasibility testing, and promoting the wide-spread deployment of new technologies through professional education and commercial partnerships. More information about the Cleveland FES Center is available at www.fescenter.case.edu. For specific information about the NCMRR/NICHD (National Center for Medical Rehabilitation Research/National Institute of Child Health and Human Development) contract award, please contact Dr. Robert Kirsch at robert.kirsch@case.edu.

About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Neurotechnology Systems, a leader in brain interface technology, is developing products to treat nervous system diseases and disorders by bringing together advances in neuroscience, computer science and engineering. Cyberkinetics' products are based on over ten years of technology development and cutting-edge neuroscience research at leading academic institutions such as Brown University, the Massachusetts Institute of Technology, Emory University, and the University of Utah.

Cyberkinetics has received FDA clearance to market the NeuroPortTM System, a neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. The NeuroPortTM System can contribute to the diagnosis and treatment of neurological conditions in patients who have undergone a craniotomy by providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity.

Cyberkinetics' BrainGateTM System is being designed to give severely paralyzed individuals, as well as individuals with motor impairment from a variety of causes, a long-term, direct brain-computer interface for the purpose of communication and control of a computer, assistive devices, and, ultimately, limb movement.

More information is available at www.cyberkineticsinc.com. For specific information about BrainGateTM clinical trials please send an email to braingateinfo@cktrial.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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