Revolutionizing Prosthetics

The summary for the Revolutionizing Prosthetics grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Defense Advanced Research Projects Agency, which is the U.S. government agency offering this grant.

Revolutionizing Prosthetics: Revolutionizing Prosthetics, BAA05-26, Proposals Due Noon ET, April 29, 2005, POC: Dr. Geoffrey Ling, DARPA/DSO; Phone: (571) 218-4674; Fax: (703) 807-4956. The Defense Sciences Office (DSO) of the Defense Advanced Research Projects Agency (DARPA) is seeking proposals to develop an advanced upper-extremity prosthesis. The vision of this program is to create a neurally controlled artificial limb that will restore full motor and sensory capability to upper extremity amputee patients. This revolutionary prosthesis will be controlled, feel, look and perform like the native limb. Submissions must provide evidence of a highly integrated, multi-disciplinary team capable of fulfilling the vision, objectives and milestones of the program. The final product will be an advanced prosthesis ready for human clinical trials including completed submission of an Investigational New Device (IND) application to the US Food and Drug Administration (FDA). An accompanying Proposer Information Pamphlet (PIP) must also be referenced to aid in production of proposals (www.darpa.mil/dso/solicitations/prosthesisPIP.htm). Successful proposals will address the program goals and specifications detailed in this BAA and in the associated PIP. A complete prosthetic upper extremity with full motor and sensory function will be delivered and function as well as a normal human arm. This prosthesis will be perceived by the patient as natural with respect to function, weight, durability and comfort. To accomplish this will necessitate novel technology in research areas such as neural control, sensory input, advanced mechanics and actuators, and prosthesis design and integration. Components should provide strength, environmental tolerance (heat, cold, water, humidity, dust, etc) and durability such that the device will last at least 10 years with normal use. While this BAA focuses on prosthetics for upper extremities, it is expected that the technologies will allow future improvements on lower extremity prosthetics as well. Specific metrics are listed in the PIP and include, in part, (1) complete transmission and accurate interpretation of afferent (sensory) and efferent (motor control) signals between the nervous system (central and/or peripheral) and the prosthesis; (2) temperature, touch (two-mm discrimination) and force (0.1 N) sensation; (3) simultaneous control of joints, (4) human-like range of motion for the elbow (one degree of freedom [DOF]), wrist (two DOF) and fingers (four DOFs each); (5) elbow flex-extend strength of up to 60 ft-lbs.; (6) pinch strength of up to 20lbs and grip strength to 70 lbs; (7) wrist flexion strength of up to 60 ft-lbs; (8) 24 hour endurance between refuel or recharge while conducting activities for daily living; and (9) operational speed up to 120 degrees/sec with a 10 msec response time. While some degree of shared local control is expected, DARPA considers the ability to provide neural control to the prosthesis to be essential to achieving the desired outcome of restoring full motor and sensory capabilities. Proposals that do not utilize neural control as a significant mechanism for controlling the prosthetic are not of interest. Achievement of program milestones/metrics will demand prompt identification of areas requiring further research and rapid incorporation of advancements made in these areas into the prosthetic device. Because of the need to quickly and safely incorporate new technologies into the final product for IND submission, successful proposals will contain an assessment/analysis of the current "state of the art" in the field of upper extremity prosthetics along with a clear statement of the integrated vision for this effort. TEAMING The goals of the prosthetic device program demand that a central element of the successful proposal will be a multi-disciplinary team of demonstrated (or established) capability. Involved fields of expertise should include, at a minimum, expertise in the clinical sciences, neurosciences, engineering, materials/biomaterials sciences, control engineering, training, medical device manufacture & pre-commercial marketing, and experience with the FDA approval process. Proposals that center solely on one research area, while neglecting the overall vision, will not be considered for funding. It is critical that the research team be built from its inception around a Systems Integrator (SI). The SI will be responsible for the overall team direction, organization, and accomplishment of all milestones and the delivery of the final product including the IND. Consequently, the SI must have a proven record of success in integration efforts of similar complexity as well as a commitment to shepherd the prosthetic development through transition. SI must demonstrate complete understanding and sharing of the DARPA vision of a fully functional upper-extremity prosthesis; SI that is strictly in the effort for project management will not be successful. As the team leader held accountable for timely delivery of the proposed work, the SI must have the authority to develop and maintain the proper team membership to ensure accomplishment of the task. DARPA will evaluate teams on their understanding of the challenges, as well as capabilities, prior experience, current data, and available facilities to conduct the proposed work. It is left to the discretion of the proposer to construct their team from the fields and researchers/companies that are necessary to carry out the effort. However, because of the importance of the neural control aspect of this effort, proposals are strongly encouraged to include more than one research component in this area. Since team composition will ultimately determine the success of this program, a teaming website is provided to facilitate these interactions and can be found at www.sainc.com/ProsthesisTeaming. PROGRAM PHASES This effort will be conducted in two 24-month phases. Proposers are requested to submit a proposal that addresses the technical effort in both phases. The goal of this program, a neurally controlled artificial limb that provides full functionality as determined by the Jebson-Taylor Hand Function Test, is extremely aggressive. Consequently, it is necessary that progress will be assessed regularly throughout the program via scheduled milestones and metrics associated with the performance of critical components. At the end of the Phase 1 period, the team's performance will be evaluated in two areas: 1) progress on each of the critical research areas as determined by appropriate metrics detailed here and in the associated PIP, and 2) a detailed systems engineering plan for the integration of the critical components into the prosthetic device. Successful Phase I teams will demonstrate significant progress towardsor enabling technologies forthe realization of the prosthetic metrics detailed here and in the associated PIP. Critical areas include demonstration of the extent to which sensory (afferent) feedback can be provided to the nervous system and approaches to overcome any sensory limitations, plus interrogation methods that can quantitatively differentiate afferent and efferent signals from prosthesis sensors and peripheral nerves. It is imperative that performers show that afferent signals can be cognitively perceived appropriately by the subject, suitability of the prosthesis design for use in transhumeral or shoulder disarticulation amputations, with a level of modularity that will enable adaptation to varying degrees of stump length. Also important is the demonstration of progress/achievement in the mechanical, environmental, interface capabilities required by the program especially: (1) chronically implantable neural interfaces, (2) full biomimetic kinematics capable of a complete grasp set and free swing kinematics exhibited by the native limb during walking locomotion, (3) inertial properties that match the lost limb, (4) effective cosmetic matching to the amputee, (5) robustness in typical indoor and outdoor environments, (6) a design amenable to direct skeletal attachment and (7) technical approaches designed to be viable in vivo for greater than 1 year. A successful integration plan will demonstrate that there is a defined application of efferent motor and afferent sensory capabilities for control of robotic arm and hand, demonstration that the strategy used to actuate the prosthesis includes proprioception and sensory feedback (i.e., the patient will be able to accomplish activity of daily living tasks in the dark), a clear strategy to integrate the prosthesis with patients. The patient must be able to wear the prosthesis for 18 hours/day without discomfort, or pathologies such as skin dehiscence, callous formation, etc after 3 months of daily use. Finally, a detailed approach should be included for incorporating the functional parameters in the prosthesis within the program goals of weight, shape, and appearance. Proposals that do not address the full integration of component technologies into an upper limb prosthesis or do not plan for the appropriate approval process and product commercialization are generally not of interest. Based on the results of Phase I, there may be a downselect. Phase II, for those selected to continue, will culminate in delivery of the final product, an advanced prosthesis ready for human clinical trials including completed submission of an Investigational New Device (IND) application to the US Food and Drug Administration (FDA). RESEARCH INVOLVING HUMAN USE Proposals selected for funding are required to comply with provisions of the Common Rule (32 CFR 219) on the protection of human subjects in research (http://www.dtic.mil/biosys/downloads/32cfr219.pdf) and the DoD Directive 3216.2 (http://www.dtic.mil/whs/directives/corres/html2/d32162x.htm). All proposals that involve the use of human subjects are required to include documentation of their ability to follow Federal guidelines for the protection of human subjects. This includes, but is not limited to, protocol approval mechanisms, approved Institutional Review Boards (IRB), and Federal Wide Assurances. These requirements are based on expected human use issues sometime during the entire length of the proposed effort. For proposals involving "greater than minimal risk" to human subjects within the first year of the project, performers must provide evidence of protocol submission to a Federally approved IRB at the time of final proposal submission to DARPA. For proposals that are forecasted to involve "greater than minimal risk" after the first year, a discussion on how and when the proposer will comply with submission to a Federally approved IRB needs to be provided in the submission. More information on applicable Federal regulations can be found at the Department of Health and Human Services Office of Human Research Protections website (http://www.dhhs.gov/ohrp/). PROPOSAL REQUIREMENTS The accompanying Proposer Information Pamphlet (PIP) contains necessary details regarding program planning and objectives as well as guidelines for proposal preparation, submission and evaluation that are not contained in this BAA (see www.darpa.mil/dso/solicitations/prosthesisPIP.htm). Proposals shall consist of two volumes: Technical and Cost. Specific attention should be paid to planning on the systems level, including a clear tasking of the systems integrator. PROPOSALS ARE DUE TO THE ADDRESS SHOWN BELOW NO LATER THAN NOON ET, April 29, 2005. Proposals submitted by fax will not be accepted. ADDRESSES FOR SUBMISSION OF FULL PROPOSALS: Web address for Full Proposal Submission: http://www.sainc.com/dso0526/ DARPA/DSO, ATTN: BAA05-26 3701 North Fairfax Drive Arlington, VA 22203-1714 Electronic Mail: [email protected] Related URLs: BAA 05-26: http://www.darpa.mil/baa/#dso PIP for BAA 05-26: http://www.darpa.mil/dso/solicitations/prosthesisPIP.htm Teaming Website BAA 05-26: www.sainc.com/ProsthesisTeaming FAQ for BAA 05-26: http://www.darpa.mil/dso/solicitations/prosthesisFAQ.htm Point of Contact: Geoffrey Ling Program Manager, DSO Phone (571) 218-4674 Fax (703) 807-4956 Email: [email protected] Only unclassified proposals will be accepted under this BAA.