Causes Associated With Small Fiber Neuropathy (SFN).

• Conditions: Small Fiber Neuropathy

• Registration Number: NCT04170205
• Lead Sponsor: University Hospital, Brest

Brief Summary

Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-11-13
• Study Start: 2019-11-15
• Study First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Age of majority (>18 years old)
• Clinically managed patient at Brest University Hospital
• Patient who had a skin biopsy with anatomopathological examination for SFN performed at the University Hospital of Brest

Exclusion Criteria

• Under age of majority (<18 years old)
• Patient not followed at Brest University Hospital
• Refusal to participate to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of etiologies associated with SFN	1 year	Source population will be patients with symptoms that may be related to SFN, who have performed a biopsy for SFN.; Patient will be considered to have SFN if he or she has a decrease in intra-epidermal distal density at nerve endings below the 5th percentile and at least one clinical sign in favour of small fibre neuropathy.; Clinical signs in favour of SFN are as follows : Sensitive symptoms: burns, stings, numbness, tingling, hot/cold sensations, electric shocks, hyperesthesia, allodynia, intolerance of bed sheets, pruritus, restless legs.; Vegetative symptoms: erectile disorders, dry syndrome, sweating, hot flashes, vertigo/discomfort (orthostatic hypotension), digestive and/or urinary disorders, resting tachycardia, palpitations; Vascular symptoms: erythromelalgia, acrosyndrome

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France