Intraepidermal Nerve Fiber Density Determination Clause Samples

Intraepidermal Nerve Fiber Density Determination. Intraepidermal nerve fibers are nociceptive C-fibers that are easily accessible from simple punch skin biopsies, and are quantifiable and reproducible. Small unmyelinated nerve fibers are easily and frequently damaged in diseases such as diabetes. A reduction in IENFD correlates with examination findings and symptoms of neuropathy. However, unlike large myelinated nerve fibers, small nerve fibers have a capacity for regeneration, even over short periods of time. There is a strong correlation between neuropathy severity and IENFD (▇▇▇▇▇▇▇ ▇▇ et al Neurology, 2009), and results are highly reproducible and reliable. Intra-epidermal nerve fiber biopsy is a powerful tool for defining pathological changes to nerve fiber density and has the potential to provide a means of assessing drug effects in a smaller number of patients as compared with patientive pain measures. In preclinical studies, ricolinostat-associated functional improvements have consistently been associated with restoration of IENFD after experimentally induced nerve injury. Examination of IENFD in humans is intended to help understand whether any observed effects on pain and other neuropathic signs and symptoms are mediated by improvement in nerve function, and also to help assess whether ricolinostat has structural effects on peripheral nerves. The procedure is rapid (5-10 minutes), performed as an office procedure, and involves minimal discomfort or risk to patients. The biopsy site is ~ 3 mm, and heals with a ‘band-aid.’ Detailed procedural instructions will be provided in the Study Reference Manual.
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