Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 24, 2020

Keywords

ClinConnect Summary

This clinical trial is looking to see if a treatment called non-invasive vagus nerve stimulation (VNS) can help people with axial spondyloarthritis (SpA) who haven't found relief from traditional medications. The study will compare the effects of VNS to a placebo, which is a sham treatment that doesn't provide any therapeutic effect, over an 8-week period. Researchers will measure changes in disease activity, pain levels, and overall quality of life to determine if VNS is more effective than the placebo.

To participate in this trial, individuals must be between 18 and 90 years old and have been diagnosed with axial SpA for at least a year. They should have active symptoms that have not improved despite using multiple medications, including anti-inflammatory drugs and biologic therapies. Participants will receive weekly treatments and complete assessments to track their progress. This study is not yet recruiting, so it's a good time to learn more about it and see if it might be a potential option for those struggling with this condition.

Gender

ALL

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.