Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies (ESNV-SPA II)
Axial Spondyloarthritis
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring axial spondyloarthritis, vagus nerve stimulation
Eligibility Criteria
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A: active stimulation then placebo stimulation
Group B: placebo stimulation then active stimulation
VNS active stimulation: Use of device (Tens Eco Plus SCHWA MEDICO™) for 8 weeks, then VNS placebo for 8 weeks. The two stimulation periods will be separated by a 4 +/- 1 weeks wash-out period. The VNS placebo stimulation period being the control one.
VNS placebo for 8 weeks, then VNS active stimulation Use of device (Tens Eco Plus SCHWA MEDICO™) for 8 weeks. The two stimulation periods will be separated by a 4 +/- 1 weeks wash-out period. The VNS placebo stimulation period being the control one.