IMPLANTABLE DEVICE FOR THE REPAIR OF THE INJURED NERVES

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The final objective of the proposed research is the assessment of a galvanic nerve guide (GNG) device as an adjunct to the repair of the damaged human peripheral nervous system (PNS). Such a device could potentially be used to treat extensive injuries of the PNS. Studies by this and other laboratories, similar devices have proven efficacious in facilitating repair of the transected and reanastomosed rat sciatic nerve. The feasibility of the device in facilitating recovery of function in a severely damaged nerve such that results in a physical discontinuity (or "gap") in the nerve will be explored in the present experiments. In pilot studies, behavioral and morphological data collected in rats treated for four weeks with a GNG device after transection lesions resulting in a physical gap in the sciatic nerve suggested an increase in the rate of recovery of behavioral function, as well as an increase in the rate of regeneration of axons in the distal segment. It is therefore important to more rigorously test such treatment in this injury model. As a first step, a possible facilitated recovery of function of the damaged rat sciatic nerve will be determined over several treatment periods using the Sciatic Functional Index (SFI) measurement of spontaneous walking behavior. Additionally, correlates to this behavioral determination will include "foot- flick" responses, and electrophysiological measurements of compound action potentials, nerve conduction velocity and twitch tension. Morphometric analyses will also be performed as an additional corrolary to the functional data. Long-term safety and efficacy studies of the GNG device in later SBIR phases will serve as a prerequisite for future clinical studies. This technology has great potential for the treatment of trauma in the PNS and possibly the CNS, yet its clinical acceptance and therefore commercial success still depends upon basic scientific data.