Mar 052011

Since 2005, DARPA (the Defense Advanced Research Projects Agency) has invested more than $100M into development of the brain-machine interfaces (BMIs) by sponsoring two programs, Revolutionizing Prosthetics and Human-Assisted Neural Devices. Most of that funding went into creation of two BMI-controlled artificial arms – the 10-degrees-of-freedom (DoF) DEKA “Luke” Arm by DEKA R&D Corp. and the 22-DoF Modular Prosthetic Limb (MPL) by Johns Hopkins University together with University of Pittsburgh and California Institute of Technology. A smaller effort to develop the 3-DoF BMI-controlled artificial arm is also underway in Germany by the company Otto Bock HealthCare GmbH. It now appears that DARPA’s investment into neuroprosthetic control of the arm may begin to materialize as early as this summer. The BMI control of the MPL arm will be made possible by the array of penetrating electrodes implanted into the motor cortex of five quadriplegic patients. The silicon-based array will record the multi-unit activity in the cortical area that controls the arm movement and the recorded information will be used to predict the intended direction and force of movement. Penetrating silicon-based arrays have been already successfully tested in monkeys, demonstrating the feasibility of decoding the intent of different movements from cortical signals. The biggest remaining problem is a rapid deterioration in the quality of neural recordings from cortical arrays, ranging from several months to a year.  A range of strategies can potentially overcome this problem: 1) by making the electrodes less stiff, 2) by removing the wires tethering the array to the skull, and 3) by using a biomimetic array coating to improve its biocompatibility and reduce the immune response. It is unlikely that any of these novel strategies will actually be used in the first generation of cortical arrays for the MPL control. Nevertheless, the upcoming clinical trial will be a positive event for the BMI R&D community after suffering a setback from the failed BrainGate trial three years ago. Progression of the BMI-MPL clinical trial will be closely monitored and guided by the FDA, which, after extensive talks with DARPA, recently created the Innovation Pathway specifically for such pioneering and transformative medical technologies. By utilizing this Pathway, the FDA aims to cut the premarket approval process time in half (to 150 days or less), suggesting a smooth commercialization path for the BMI-MPL after conclusion of its clinical trials.

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