Spaulding, a teaching affiliate of Harvard Medical School, is a premier rehabilitation facility in the United States and the second rehabilitation center to participate in the study.
Cyberkinetics received regulatory clearance from the U.S. Food and Drug Administration (FDA) in March of 2004 to study the BrainGate Neural Interface System under an Investigational Device Exemption (IDE).
In the first several weeks of the study, the first patient enrolled through the Sargent Rehabilitation Center in Rhode Island has successfully been able to use his thoughts and the BrainGate System to operate a computer, environmental controls and a robotic limb.
The pilot (feasibility) study protocol provides for the enrollment of up to 5 individuals with quadriplegia (unable to use their arms and legs) who are between the ages of 18 and 60 and who meet the study’s selection criteria. The 2 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 patients can achieve using thoughts.
Initial clinical and scientific findings from the study were recently presented at the annual meetings of the American Academy of Physical Medicine and Rehabilitation.
The BrainGate Neural Interface System is an investigational brain-computer interface 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 silicone chip about the size of a baby aspirin with one hundred electrodes, each thinner than a hair, that detect the electrical activity of neurons.
The sensor is implanted on the surface of the area of the brain responsible for movement, the primary motor cortex. A small wire connects the sensor to a pedestal which is mounted on the skull, extending through the scalp. An external cable connects the pedestal to a cart containing computers, signal processors and monitors, which enable the study operators to determine how well a study participant can control his neural output.
The ultimate goal of the BrainGate development program is to create a safe, effective and unobtrusive universal operating system which will allow physically disabled people to quickly and reliably control a wide range of devices using their thoughts, including computers, assistive technologies and medical devices.
The Spaulding Rehabilitation Hospital, home to Harvard Medical School’s Department of Physical Medicine and Rehabilitation, is the only rehabilitation hospital in New England ranked among the nation’s best in U.S. News & World Report.
Cyberkinetics is focused on treating diseases and disorders of the nervous system through neurotechnology.
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