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

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Axial Spondyloarthritis
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (1)

92380

Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP, Garches

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT04286373 - Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies | Biotech Hunter | Biotech Hunter