NCT04286373Not yet recruiting
Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies
Randomized Cross Over Study Assessing the Effectiveness of Non-invasive Vagus Nerve Stimulation in Patients With Axial Spondyloarthritis Resistant to Biotherapies
Source: ClinicalTrials.gov · Last updated 27 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 31 Jan 2020
- Start date
- Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT04286373
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Sept 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with cochlear implant;
- Previous VNS treatment;
Other illness
- Cardiac arrhythmia;
- Patients with known heart disease;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP Coordinator of this site? Confirm its status | Garches | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.