Normative Data of Intra-epidermal Nerve Fiber Density
This trial is active, not recruiting.
|Sponsor||University Hospital, Strasbourg, France|
|Start date||December 2011|
|End date||December 2012|
|Trial size||300 participants|
|Trial identifier||NCT01498211, 4961|
Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||single group assignment|
Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.
time frame: 1 month
Male or female participants from 20 years up to 80 years old.
Inclusion Criteria: - Man or woman between 20-80 years old - Normal subjects without pain and neurological impairment - No history of neurological disorder - Normal neurological examination - Normal ECG - Normal clotting sample from less than 6 months - Available by phone Exclusion criteria : - History of alcoholic intoxication or chemotherapy - History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis - Contraindication to xylocaïn with adrenalin - At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency - Innate or acquired immunosuppression - Innate or acquired clotting abnormality
|Official title||Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin|
|Principal investigator||Nicolas COLLONGUES, MD|
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