Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01989819
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2013-11-06
Brief Title:
Primary Sjögren Syndrome
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeuroSenSS
Brief Summary:
Primary Sjögren syndrome pSS is an inflammatory autoimmune multiorgan disease often involving the central and peripheral nervous systems Fifteen to twenty percent of patients with the primary Sjögrens syndrome have neurological complications involving the peripheral nervous system Although some patients have large fiber neuropathy around forty percent of patients with Sjögrens syndrome experience neuropathic pain with normal electrodiagnostic studies Although these patients may be diagnosed with fibromyalgia or depressive symptoms some have been shown to have small fiber neuropathy SFN A recent study proved that more than 90 of pSS patients with such neuropathic pain have SFN Fauchais 2010 188
The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular cytokinic or auto-antibody response Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation Moreover pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy
Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies
The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular cytokinic or auto-antibody response Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation Moreover pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy
Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None