Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Axial Spondyloarthritis Resistant to Biotherapies
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Axial Spondyloarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The efficacy of non-invasive VNS therapy in patients with axial SpA has never been studied. This study will assess the benefit-risk balance of the therapy through a randomized double-blind cross over clinical trial. This multi-center study will be conducted in rheumatology departments of 17 public h...
The efficacy of non-invasive VNS therapy in patients with axial SpA has never been studied. This study will assess the benefit-risk balance of the therapy through a randomized double-blind cross over clinical trial. This multi-center study will be conducted in rheumatology departments of 17 public hospitals in France. A transcutaneous vagus nerve stimulator Tens Eco 2 SCHWA MEDICO™ France will be used in this study. Before the beginning of the study, a VNS practical training seminar will be organized in order for all future investigators. All patients eligible for this study must have been previously treated according to national and international guidelines for patients with axial SpA. Adult patients with axial SpA diagnosed and followed for at least one year, insufficiently relieved despite optimal drug management, including at least two lines of biotherapies tested for at least 6 months, will be enrolled in this study. The duration of participation (treatment + follow-up) for each patient: 7 months.
Tracking Information
- NCT #
- NCT04286373
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eric AZABOU, MD, PhD Clinical Neurophysiology Laboratory, Department of Physiology and Functional Explorations, Raymond Poincaré Hospital, APHP Study Director: Maxime Breban, MD, PhD Department of Rheumatology, Ambroise Paré Hospital, APHP
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