Objective:<\/b> Develop an implantable neural interface system to provide quadriplegic patients with an output signal directly from the brain to a computer.<\/p>\n
Design:<\/b> Preclinical studies, prototype testing, and clinical trial.<\/p>\n
Setting:<\/b> Animal laboratory, outpatient clinics, patient homes.<\/p>\n
Participants:<\/b> Macaque monkeys and five quadriplegic patients.<\/p>\n
Intervention:<\/b> Implantation of BrainGate microelectrode array sensor on the motor cortex surface. The array is connected to an amplifier, a signal processor, a decoder, and a patient-computer interface. The decoder correlates neural signals to desired actions using mathematical algorithms (linear regression).<\/p>\n
Main Outcome Measures:<\/b> Safety assessment and ability to move a cursor to targets on the computer screen.<\/p>\n
Results:<\/b> 8 implants were placed in six macaques for an average of 10.2 months\/implant. Side effects included 3 minor skin erosions (< 5 cm) and 1 treatable superficial skin infection around the connector. One implant recorded only one neuron and was explanted; another stopped recording at 12 months. For loosening, one connector required a strap. Three macaques were trained in a cursor control task. On the first decoding\/testing day, all subjects achieved instant neural control of a cursor after a 15-minute calibration period. The FDA and local IRBs have approved a feasibility study, and the authors hope to present human data by 10\/04.<\/p>\n
Conclusions:<\/b> Previous monkey studies established that neural activity can be decoded to generate useful output signals (Serruya et al., 2002 Nature 416:141). By deriving signals directly from the cerebral cortex, the BrainGate may allow human patients with severe motor impairments to control a cursor for the Internet, assistive software, and standard desktop activities.<\/p>\n","protected":false},"excerpt":{"rendered":"
Objective: Develop an implantable neural interface system to provide quadriplegic patients with an output signal directly from the brain to a computer. Design: Preclinical studies, prototype testing, and clinical trial. Setting: Animal laboratory, outpatient clinics, patient homes. Participants: Macaque monkeys and five quadriplegic patients. 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