Tests a non-invasive nerve stimulation device for axial spondyloarthritis
Tests device-based vagus nerve stimulation against placebo stimulation in adults with axial spondyloarthritis.
Plain-language title generated from the registry record
Registry title: Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies
Key facts
- Where
- Garches, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT04286373, who can take part
Where in France
- Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHPGarches, FranceNo longer taking part
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
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT04286373
- Record updated
- 27 April 2025
- Original description
The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group).Read full original descriptionShow less
Randomized Cross Over Study Assessing the Effectiveness of Non-invasive Vagus Nerve Stimulation in Patients With Axial Spondyloarthritis Resistant to Biotherapies
The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group).
The secondary objectives of the Clinical Investigation are to show differences in disease evolution between the active and placebo periods of 8 weeks treatment with active VNS versus placebo VNS of the following items:
1. Change in disease activity according to "ASAS40" criteria 2. Obtaining a partial remission according to the ASAS definition 3. Change in BASFI 4. Change in C-reactive protein (CRP)serum level and erythrocytes sedimentation rate (ESR), 5. Change in ASDAS_CRP and ASDAS_ESR 6. Difference in levels of circulating cytokines, IL-6, IL-23, IL-17, IL-33 and of matrix metallopeptidases (MMP3-8-9). 7. Change in quality of life : assessment according to the following indexes: SF-36, AS Quality of Life (ASQOL) 8. Change in Health Index of patient with SpA (ASAS HI) and of the Productivity at Work Index (WPI) 9. Change in fatigue (BASDAI 1st question) and global pain 10. Change in Anxiety and Depression Assessment (HAD) 11. Change in BASMI 12. Change in non-steroidal anti-inflammatory drugs (NSAID) intake score.
Inclusion: Patient from 18 to 90 years with axial SpA, meeting the ASAS classification criteria, followed for at least one year, with presence of radiological sacro-illitis (ankylosing spondylitis) or not; Patient suffering active SpA, with or without treatment, having a total BASDAI score ≥ 4 (0-10) at baseline and a score of global pain ≥ 4 (0-10); SpA insufficiently relieved despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 3 months (or less in case of intolerance) and at least two lines of biotherapies or discontinued SpA treatments due to intolerance, contraindication.
Exclusion: Patients with cochlear implant; Previous VNS treatment; Cardiac arrhythmia; Patients with known heart disease; Patient under guardianship; Hypotension; Asthmatic patients; Refusal to participate in the study or to sign the informed consent; Pregnant or breastfeed woman; No affiliation to a social security scheme; Incapacity to attend the weekly appointment during the study period; 12- Head trauma with fracture of rock. In case of skin lesions of the left ear, recruitment will be delayed until these lesions are healed.