SOLICITATION NOTICE
A -- Restoration of Hand and Arm Function by Functional Neuromuscular Stimulation
- Notice Date
- 3/18/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, MD, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NIH-NINDS-05-03
- Response Due
- 5/31/2005
- Archive Date
- 6/15/2005
- Description
- 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 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 notice is not a Request for Proposals (RFP). THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. Request for Proposal (RFP) No. NIH-NINDS-05-03 will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) or through the NINDS website at the following URL address: (http://www.ninds.nih.gov/funding/currentrfps.htm) 15 or more calendar days after the issuance of this synopsis. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency. Refer to number note 26. *****
- Record
- SN00771473-W 20050320/050318211839 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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