Checking for nerve damage in people with Sjögren's syndrome using a quick skin test
Uses a quick skin test to check adults with Sjögren's for small nerve damage.
Plain-language title generated from the registry record
Registry title: Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Key facts
- Where
- Amiens, FranceSee the site
Where in France
- CHU AmiensAmiens, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire, Amiens
- Trial code
- NCT07917442
- Record updated
- 4 November 2026
- Original description
The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases. Among peripheral nervous system complication, SFN appears to be prevalent. However the association between pSS and SFN has been scarcely evaluated. There are not many relevant studies using similar methodology to evaluate pSS patients for small fiber dysfunction. Furthermore, autoimmune mechanisms are thought to play a key role in SFN pathogenesis in pSS and the association between SFN and specific immunological profiles has been poorly studied. So the aim of this study is to evaluate the prevalence of SFN in pSS patients by using the Sudoscan which is a fast and non- invasive tool. The Sudoscan could offer an accessible alternative for early SFN detection, improving patient management. The secondary purpose is to analyze systemic and immunological profiles, as well as disease's activity and quality of life of patients with pSS-related SFN.Read full original descriptionShow less
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases. Among peripheral nervous system complication, SFN appears to be prevalent. However the association between pSS and SFN has been scarcely evaluated. There are not many relevant studies using similar methodology to evaluate pSS patients for small fiber dysfunction. Furthermore, autoimmune mechanisms are thought to play a key role in SFN pathogenesis in pSS and the association between SFN and specific immunological profiles has been poorly studied. So the aim of this study is to evaluate the prevalence of SFN in pSS patients by using the Sudoscan which is a fast and non- invasive tool. The Sudoscan could offer an accessible alternative for early SFN detection, improving patient management. The secondary purpose is to analyze systemic and immunological profiles, as well as disease's activity and quality of life of patients with pSS-related SFN.
Inclusion: Age ≥ 18 years; Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016; Body Mass Index between 18 and 35 kg/m².
Exclusion: Secondary or unconfirmed Sjögren's syndrome,; Other conditions that may cause small fiber neuropathy,; type 2 diabetes,; Age < 18 years, Use of medications that could interfere with Sudoscan results and which could not be discontinued before inclusion,; excessive alcohol consumption,; sarcoidosis; obesity.