Normative Data of Intra-epidermal Nerve Fiber Density

University Hospital, Strasbourg, France

Status: Completed

Conditions: Healthy

Treatments: Procedure: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01498211

4961

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Biopsy

Experimental group

Treatment:

Procedure: Biopsy