Status:
NOT_YET_RECRUITING
Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 st...
Detailed Description
This multi-center study will be conducted in rheumatology departments of 14 public hospitals in France. The study is part of the SMART-VNS (TM) project: a Structured Multidisciplinary Program for Adv...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04286373
Start Date
September 1 2025
End Date
December 1 2026
Last Update
April 27 2025
Active Locations (1)
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1
Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP
Garches, Hauts-de-seine, France, 92380