Ignite Creation Date:
2024-05-05 @ 10:18 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01078857
Status:
UNKNOWN
Last Update Posted:
2010-03-02
First Post:
2010-02-28
Brief Title:
Small-fiber Neuropathy in Chronic Kidney Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Small-fiber Neuropathy in Chronic Kidney Disease
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 and endocrine profiles on the development of small-fiber neuropathy 5 the relationship between the small-fiber neuropathy and pruritus or restless leg syndrome and 6 the pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD related neuropathy The results of the study will provide important insights in the understanding of the pathogenesis and the prevention and new treatments of small-fiber neuropathy in CKD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None