THIS PAGE IS ARCHIVED MATERIAL.
|Principal Investigator||Affiliation||Contract Number||Link|
|Tom Mortimer, Ph.D.||Case Western Reserve University||N01-NS6-2346|
ARTICLE C.1 BACKGROUND
Stimulating electrodes that are in close contact with peripheral nerves as well as epimysial and intramuscular electrodes that stimulate nearby nerve branches are being used singly or in combination in a variety of clinical applications of functional neuromuscular stimulation (FNS) including feasibility studies of hand grasp, standing and walking, bladder and bowel evacuation, and breathing. Although limited restoration of function is achieved with currently available electrodes, electrode performance continues to limit the utility of FNS systems and this prevents their more widespread application in neurologically disabled individuals. Each electrode has limitations that make safe, stable, selective, graded, length-independent activation of specific muscles difficult to achieve in FNS.
The objective of this research is to develop stimulating electrodes suitable for chronic FNS in humans that permit safe, reliable, graded activation of selected muscles. In order to encourage the broadest competition, the particular type of electrode and the muscles to be activated are not specified. The offeror will define this focus in association with a collaborating clinical research group. The research will concentrate on developing electrodes that are capable of selectively activating specific functional muscle groups required by the collaborating clinical group. Offerors are encouraged to consider innovative approaches to the design of electrodes with a focus on obtaining reliable, selective, controlled, graded stimulation. Human studies are not a part of this proposed research but it is expected that the research effort will conclude at a point where human studies will be the next logical step.
This contract represents a competitive renewal of an ongoing NINDS contract (NS3-2300). A current bibliography listing publications resulting from NPP studies on FNS and related studies is available free of charge from the Neural Prosthesis Program, NIH, Federal Building, Room 916, Bethesda, MD 20892-9170.
ARTICLE C.2. STATEMENT OF WORK
I. Independently and not as an agent of the Government, the contractor shall exert its best efforts to design, fabricate, and test, in an animal model, electrodes for use in functional neuromuscular stimulation (FNS) systems. This work shall be done in collaboration with a group actively involved in a clinical FNS investigation but this contract will not support the clinical program. Chimpanzees shall be excluded as a potential research animal.
Specifically the contractor shall:
A. Identify a collaborating clinical group, determine with them the limitations of currently available electrodes for their FNS application, and propose approaches to overcome these limitations.
B. Design and fabricate new electrodes and leads to functionally activate muscles identified in (A). Any electrode design must consider the safety and reliability requirements implicit in the development of an electrode for rehabilitation use in humans. Special consideration shall be given to:
1. the selectivity of muscle activation with a goal of full activation of the target muscle with minimal spillover of stimulation to other anatomical muscles or afferent nerves
2. the stability of the activation response over the full range of motion of the muscle and the stability of the activation response over time
3. the dynamic force range of muscle activation with the goal of producing a range of forces comparable to the normal physiological range.
C. Evaluate the electrodes developed in (B) in a suitable animal model of the proposed application(s) and determine how they function relative to the performance goals specified in (B).
D. Based on the results of (C) design improved electrodes as needed.
E. By the end of the contract period, in collaboration with the clinical group, determine whether the electrodes developed are ready for human feasibility testing. If they are not ready, outline further development, testing and/or performance characteristics that must be achieved. If they are ready, outline a plan for human feasibility testing.
F. Cooperate with other Neural Prosthesis Program investigators by fabricating and delivering at least 15 of the most promising electrodes to other investigators for evaluation by the end of the third year of the contract.
Last Modified November 24, 2008