An observational study in Small Fiber Neuropathy, sponsored by University Hospital, Brest. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by University Hospital, Brest · Observational
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.
47 studies on the registry are indexed under Small Fiber Neuropathy; 12 are open to participants now.
This study's planned enrollment of 450 is above the median of 86 across 18 observational studies indexed under Small Fiber Neuropathy.
Browse Small Fiber Neuropathy studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with clinical symptomatology in favour of SFN who have been subjected to skin histological examination for SFN
Exclusion Criteria:
Prevalence of etiologies associated with SFN
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
Time frame: 1 year
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest