Informations générales (source: ClinicalTrials.gov)
Randomized Cross Over Study Assessing the Effectiveness of Non-invasive Vagus Nerve Stimulation in Patients With Axial Spondyloarthritis Resistant to Biotherapies (ESNV-SPA)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2025
décembre 2026
29 avril 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP - 92380 - Garches - Hauts-de-seine - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- Patient under guardianship;
- Cardiac arrhythmia;
- Patients with cochlear implant;
- Patients with known heart disease;
- 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;
- Previous VNS treatment;
- 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.