Controller Development for Upper Limb Movement

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Spinal Cord and Musculoskeletal Disorders and Assistive Devices Program (SMAD), within the National Center for Medical Rehabilitation Research Center of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Health, intends to negotiate on a sole source basis, under the authority of 42 U.S.C. 253- (1) and FAR 6.302 - 1(a) (2) (ii), a new contract with Case Western Reserve University, entitled "Controller Development for Upper Limb Movement". The new contract is necessary for completion of the contract project. This modification will allow the Case Western Reserve University and its subcontractors the additional time needed to recruit and study more participants with complete upper limb paralysis due to preferably cervical spinal cord injury and/or possibly brain stem stroke and acquire more significantly powered study endpoints, as well as time to process the data and further refine the algorithms for the controller (e.g. deliverable). The new contract is to continue this study for approximately 24 months. The contract goal continues to be the development of a prototype controller that is designed for future use as an external Functional Electrical Stimulation (FES) control system for the restoration of function of one or more movements in the paralyzed upper limbs. The ongoing development of the controller includes a design that incorporates simulation technology for testing and a real-time external FES system that is interfaced with brain signals that are recorded from the motor cortical area of the participant. The extension of the project will enable the highly unique and experienced team of investigators to recruit and test additional participants and acquire and analyze patient data that will ultimately enhance the controller, making it a more powerful tool for translating cortical signals that would eventually drive the FES system for upper limb movement. The additional data will aid in the refinement of the controller and the testing/training technologies necessary for future devices supporting a variety of paralysis. Any new participants for this contract will be implanted with the BrianGate 2 Neural Interface System. To date this study has enabled significant advances in the implementation of the BrainGate implant technology for human participants, the sophisticated software development and computer driven testing of the implant, and the collection and analyses of human cortical signal data pertinent to the eventual control of upper limb motor movement. This research has involved a well established team of investigators who bring unique medical, bioengineering and technological experience, specialized resources and novel approaches that have been essential for the forward progress of the project. There is no other source presently known to NICHD that has access to the currently accrued data and technologies that are necessary for the completion of this complex clinical trial. It would cost the Government significant time and effort to train, recruit, and duplicate the expertise, technologies and clinical resources acquired by Case Western Reserve University and its subcontractors over the past 5 years. If any contractor believes it can perform the above requirement, it may submit, within 15 days of publication of this notice, an original and three (3) copies of a capability statement, which will be considered by this agency (plus an electronic copy to ls59u@nih.gov) to: Lynn Salo, Contracting Officer, NICHD CMB, NIH, 6100 Executive Building, MSC 7510, Bethesda, Maryland 20892-7510 (or overnight courier: 6100 Executive Blvd., Rockville, Maryland 20852). Phone number: 301-435-6962, and FAX number: 301-402-3676. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Authority: 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1(a)(2)(ii). No collect calls will be accepted. This requirement is defined as code 541712 under the North American Industry Classification System (NAICS).