Notice Number: NOT-NS-05-007
Release Date: March 22, 2005
RFP Release Date: April 1, 2005
The NINDS has a requirement for the continued research and development of functional neuromuscular stimulation (FNS) systems to restore coordinated, directed upper extremity function by synergistically controlling stimulated and voluntary movements in tetraplegic individuals with high, middle, and low cervical injuries. Evaluation of these FNS systems will be conducted in human subjects who have paralyzed upper extremities as a result of upper motor neuron lesions. A major emphasis of this work is to produce functionally relevant quantitative measures; any testing performed should primarily emphasize quantitative results rather than qualitative or descriptive research findings.
This project involves research and development leading to the complete development of systems for FNS devices designed for subjects with high, middle, and low cervical injuries. This project will focus on the sufficiency of FNS in the restoration of coordinated upper extremity function movements such as hand grasp, pronation/supination, elbow extension and shoulder movement. To make the systems practical and attractive for use, the FNS system components will need to be made fully implantable, including sensors that provide the system and/or the user with sensory feedback and a paradigm for control. The contractor shall establish safety and feasibility of the proposed approach, the ability of the FNS system to synergistically control stimulated and voluntary movements, determine the most effective sensory and control components, and determine the quantitative metrics needed for testing system efficacy in restoration of upper extremity movements in human subjects. Spinal cord injury induces changes in muscle properties that vary between individuals based on the extent of denervation and disuse. Therefore, the following issues should be addressed: assessment of spasticity and the effects of muscle denervation, weakness, fatiguability and/or other complications on FNS system performance. While this contract does not constitute a clinical trial, it is expected that a sufficient number of human subjects will be enrolled in the study to enable statistical confidence in the findings, and establish appropriate inclusion/exclusion criteria and endpoints for planning definitive efficacy trials. A major goal of this effort is to enable transition to the commercial sector of technologies that can benefit disabled individuals. Consequently, offerors will be expected to include a commercial transition plan for relevant milestones, deliverables, and accomplishments resulting from this effort.
Any resultant contractor will also be expected to cooperate with other investigators supported by the Neural Prosthesis Program (NPP) largely driven by the National Institute of Neurological Disorders and Stroke as well as other institutes at the NIH. Of particular relevance to this RFP, The National Institute of Child Health and Human Development (NICHD) is planning to support an effort to fabricate a prototype FNS controller capable of translating motor cortical signals to signals necessary to drive a FNS system. The contractor for this RFP will be expected to collaborate with the selected NICHD performers.
This RFP represents a competitive renewal of research efforts currently being performed under a contract with the Case Western Reserve University.
It is anticipated that one cost-reimbursement type contract, with a 30-month base period, and one 30–month option period will be made on or about September 2005. This acquisition has been designated as full and open competition under the North American Industrial Classification System (NAICS) code 541710. The solicitation will be available electronically on or about April 1, 2005. RFP NIH-NINDS-05-03 will be available at the FedBizOpps Website: http://www.fedbizopps.gov and at the NINDS public website: http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm). Proposals will be due on or about May 31, 2005. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet sites for any possible solicitation amendments that may be issued by the Government. All responsible sources may submit proposals which will be considered by the Government. This advertisement does not commit the Government to award a contract.
Inquiries may be directed to:
Contract Specialist, Contracts Management Branch, DER
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Boulevard
Suite 3287, MSC 9531
Bethesda, Maryland 20892-9531
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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