Primary Sjögren Syndrome (NeuroSenSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01989819
Recruitment Status : Recruiting
First Posted : November 21, 2013
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):
University Hospital, Limoges

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 Sjögren's syndrome have neurological complications involving the peripheral nervous system. Although some patients have large fiber neuropathy, around forty percent of patients with Sjögren's 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.

Condition or disease Intervention/treatment
Primary Sjögren's Syndrome Other: skin biopsy

Study Type : Observational [Patient Registry]
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Study Start Date : September 2012
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
patients with Sjögren's syndrome
A skin biopsy will be performed in patients
Other: skin biopsy
control group
A skin biopsy will be performed in control group
Other: skin biopsy
non auto-immune small fiber neuropathies

Primary Outcome Measures :
  1. To evaluate the cutaneous lymphocytic infiltration [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Cutaneous infiltration T, B and Th17 [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sjögren's syndrome

Inclusion Criteria:

  • Patients with pSS according to revised European criteria and exhibiting neuropathic pain without any electromyographic abnormality will be included (Group I).
  • Age of entry into the study ≥ 18 yrs (both groups).
  • Affiliated or profit patient of a social security system (both groups).
  • Informed consent signed up (both groups).

Exclusion Criteria:

  • Chronic alcoholism
  • Type I or type II diabetes
  • Peripheral neuropathy unrelated to pSS complications
  • Coagulation disease
  • Previous allergy to xylocaine, lidocaine, prilocaine or ricin oil
  • Porphyria, methemoglobinemia
  • Patients under measure of maintenance of justice.
  • Patients unable to understand or to participate to the study.
  • Child and major patients making the object of a measure of lawful protection.
  • Patients deprived of freedom.
  • Pregnant, nursing women.
  • Participation in biomedical research within one month prior to inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01989819

Contact: Anne-Laure FAUCHAIS, MD (+33) 5 55 05 65 03

CH d'Albi Recruiting
Albi, France, 81000
Contact: Serge Madaule, MD    (+33) 5 63 47 42 86   
Principal Investigator: Serge Madaule, MD         
CHU Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Patrick Mercié    (+33) 5 56 79 57 28   
Principal Investigator: Patrick Mercié, MD         
CH de Brive Recruiting
Brive la Gaillarde, France, 19312
Contact: Bruno Abraham, MD    (+33) 5 55 92 60 40   
Principal Investigator: Bruno ABRAHAM, MD         
CHU de Lille Recruiting
Lille, France, 59037
Contact: Pierre-Yves Hatron    (+33) 3 20 44 42 95   
Principal Investigator: Pierre-Yves Hatron, MD         
University Hospital, Limoges Recruiting
Limoges, France, 87 042
Contact: Anne-Laure FAUCHAIS, MD    (+33) 5 55 05 86 21   
Principal Investigator: Anne-Laure FAUCHAIS, MD         
CH de Rodez Recruiting
Rodez, France, 12000
Contact: Françoise Brevet, MD    (+33) 5 65 55 22 80   
Principal Investigator: Françoise BREVET, MD         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Philippe ARLET, MD    (+33) 5 61 77 95 50   
Principal Investigator: Philippe ARLET, MD         
Sponsors and Collaborators
University Hospital, Limoges
Principal Investigator: Anne-Laure FAUCHAIS, MD University Hospital, Limoges

Responsible Party: University Hospital, Limoges Identifier: NCT01989819     History of Changes
Other Study ID Numbers: I10 023
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Lacrimal Apparatus Diseases
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases