Cyberkinetics reports first data from non-speaking, paralyzed participant in ongoing study of BrainGate Neural Interface system

Foxborough 05 June 2006Cyberkinetics Neurotechnology Systems Inc. announced at the recent American Society of Stereotactic and Functional Neurosurgery (ASSFN) Biennial Meeting in Boston, Massachusetts, that clinical investigators provided an update on Cyberkinetics' ongoing BrainGate Neural Interface System pilot clinical trials. Their presentations included new data from the surgical, neurological and scientific efforts that have led to the use of the BrainGate System by those with quadriplegia to control computer interfaces using thought.

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"The results from the third participant are particularly significant because we have begun to replicate the intuitive control of a computer mouse", stated John P. Donoghue, Ph.D., a founder and Chief Scientific Officer of Cyberkinetics and Director of the Brain Science Programme at Brown University. "Such control, including the ability to stop the computer cursor, for example, is directly related to a person's ability to stop other electronically controlled devices, such as a motorized wheel chair. The new data expands our previous results showing that we are able to obtain neural signals in additional participants. We believe these findings are leading to a day when this technology can be used to improve the lives of those who are paralyzed."

The preliminary performance data reported at the meeting included initial results from the third trial participant, who is unable to speak as a result of a brainstem stroke. Specifically, the third participant has been able to control a cursor with significantly greater stability, to stop cursor movement at will, and to "click" on icons using imagined movements with the aid of an enhanced BrainGate interface. In addition, among other new developments, the third participant has also used the enhanced BrainGate operating system to type messages using assistive software.

"This pilot trial continues to indicate that an implantable brain-computer interface can one day provide an operating system for patients with severe disabilities", added Tim Surgenor, President and Chief Executive Officer of Cyberkinetics. "What is most exciting is that we have recently developed several proprietary techniques for making our neural computer interface much more intuitive and controllable - which could ultimately lead to significantly greater patient utility for controlling communication devices and other computer-controlled robotics. Based on our work with these first three participants, we now have a clearer idea of the hardware and software challenges involved in moving forward, including those needed to overcome variability in the quality and quantity of signals the BrainGate System recovers and transmits, as well as moving toward more compact, fully implantable, wireless devices."

Gerhard Friehs, a founder of Cyberkinetics and a neurosurgeon involved with the BrainGate System clinical trial, also presented data from four implantation procedures and one explant procedure. To date, there have been no unanticipated adverse events associated with any of the procedures. In addition, from the explant procedure, which was completed after 16 months in vivo, Dr. Friehs reported that no clinically significant damage to the neural tissue was observed at the time of explant. Dr. Friehs also discussed the future of Cyberkinetics' neural sensing technology, including the NeuroPort Neural Monitoring System, which is designed to detect abnormal brain activity; multi-sensor implantation; the development of a long-term, wireless system and the potential for using BrainGate-based sensor technology to both sense and respond in a number of therapeutic applications, such as seizure prediction and tremor control.

Leigh R. Hochberg, M.D., Ph.D., a Principal Investigator in the BrainGate System pilot clinical trial, provided a performance update on three participants in the pilot trial for those with spinal cord injury, stroke and muscular dystrophy. He indicated that preliminary results include:

  • Neural signals have been obtained from all three participants.
  • All three participants have been able to achieve volitional modulation of the neural signals detected by the BrainGate sensor.
  • All three participants have been able to achieve control of a computer interface using the BrainGate System.

Preliminary data from a fourth participant enrolled in a pilot trial of the BrainGate System for those with Amyotrophic Lateral Sclerosis or Lou Gehrig's Disease (ALS) and other Motor Neuron Diseases is expected to be presented at a scientific conference later in 2006.

In addition to his role as Principal Investigator in the BrainGate clinical trial, Dr. Hochberg is a member of the neurology staff at Massachusetts General Hospital, Brigham and Women's Hospital and the Spaulding Rehabilitation Center. He is also Associate Investigator, Rehabilitation Research and Development Service, Center for Restorative and Regenerative Medicine, Department of Veterans Affairs, Providence, Rhode Island, as well as an Investigator in Neuroscience at Brown University. Dr. Friehs is an associate professor of clinical neurosciences at Brown Medical School. As director of trauma and functional neurosurgery at Rhode Island Hospital, Dr. Friehs specializes in diseases that interfere with patients' daily functioning.

Cyberkinetics Neurotechnology Systems Inc., an expert in the neurotechnology industry, is developing neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system.

Cyberkinetics' product development pipeline includes: the NeuroPort System, a cleared-to-market neural monitor designed for acute inpatient applications and labeled for temporary - less than 30 days - recording and monitoring of brain electrical activity; the Andara Oscillating Field Stimulator (OFS) Device, an investigative device designed to stimulate regeneration of the neural tissue surrounding the spinal cord; and the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement.

More information on BrainGate is available in the VMW November 2004 article Sargent Rehabilitation Center tests new device designed to increase independence in quadriplegic individuals.


Leslie Versweyveld

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