Causes Associated With Small Fiber Neuropathy (SFN).

Small Fiber Neuropathy Clinical Trial

— EtioNPF  

Official title:

Retrospective Study of Causes Associated With Small Fiber Neuropathies.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04170205
• Other study ID #: 29BRC19. 0218 (EtioNPF)
• Status: Not yet recruiting
• Start date: November 15, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2019
• Source: University Hospital, Brest
• Contact: Laurent MISERY
• Phone: +330298223315
• Email: laurent.misery[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small Fiber Neuropathy

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year