Clinical Trial: Small-fiber Neuropathy in Chronic Kidney Disease

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Small-fiber Neuropathy in Chronic Kidney Disease

Brief Summary: Neurological dysfunction is a common complication of late stage chronic kidney disease (CKD) and peripheral nerve system is often involved in such complication. Sensory disturbances such as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in patients of CKD. But there are still few investigations with emphasis on the changes of small-fiber nerves in CKD, and little is known about the characteristics and mechanism of small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the morphology of epidermal nerves and the subepidermal nerve plexus is an effective and minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is a non-invasive technique to investigate the thermo-nociceptive pathways mediated by small-fiber nerves. In the current study, we will use an integrated approach by combining the skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate the pathological, psychophysical and physiological aspects of small-fiber neuropathy in patients of CKD. The aims of the current study is to address the following issues: (1) the changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of skin innervation with clinical manifestations, thermal thresholds, and autonomic function; (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals,

Detailed Summary:
Sponsor: National Taiwan University Hospital

Current Primary Outcome:

  • The pathology of skin biopsy [ Time Frame: within 3 months after inclusion ]
  • Intraepidermal fiber density [ Time Frame: within 3 months after inclusion ]
  • Autonomic function [ Time Frame: within 3 months after inclusion ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Function of small-fiber sensory nerve [ Time Frame: within 3 months after inclusion ]

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: February 28, 2010
Date Started: February 2009
Date Completion:
Last Updated: March 1, 2010
Last Verified: February 2010