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

Condition(s) studied

Investigational drug(s) / intervention(s)

active stimulation then placebo stimulation: The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient. A transcutaneous vagus nerve stimulator Tens Eco Plus SCHWA MEDICO™ France with the Garches Azabou-Bao vagal electrode (the G electrode) will be used in this Clinical Investigation. VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015). The two stimulation periods will be separated by a 4 weeks wash-out period.

placebo stimulation then active stimulation: VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015). The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient. A transcutaneous vagus nerve stimulator Tens Eco Plus SCHWA MEDICO™ France with the Garches Azabou-Bao vagal electrode (the G electrode) will be used in this Clinical Investigation. The two stimulation periods will be separated by a 4 weeks wash-out period.

Study 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 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.

Eligibility

Primary outcome measure(s)

• Change according to the ASAS Response Criteria (ASAS 20) — At baseline and week 12
  Assessement of efficacy of VNS treatment: for SpA patients under VNS treatment and under placebo non-specific stimulation, to demonstrate improvement of VNS treatment, according to ASAS20 definition, greater than placebo non-specific stimulation. ASAS20 Response is defined as follows: an improvement of 20% compared to baseline and an absolute improvement from baseline of at least 1 unit, in 3 of the 4 ASAS domains: as well as no baseline deterioration of 20% and of at least one unit in the fourth domain.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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