Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis - the TRAVAGA Study

NARecruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

October 15, 2026

Study Completion Date

June 15, 2027

Conditions
Rheumatoid Arthritis (RA)
Interventions
DEVICE

Transauricular vagus nerve stimulation.

TRAVAGUS is a portable electrical vagus nerve stimulator device that non-invasively activates the auricular branch of the vagus nerve in the left ear. The system consists of two units, the electrical stimulator and the ear electrodes that are mounted in a headset. The electrical signals are delivered transcutaneously to the ear via two separate cables connected to two aluminium electrodes. There is no need for electrode gel application on the auricular skin, since the conductivity of the two metallic electrodes is fully sufficient for functional electrical contact. The device is powered by 4 x 1,5V AAA batteries. The electrical source is a CE-marked tens unit termed STIM-PRO X9+, AXION GmbH, Leonberg, Germany. The investigational headset with auricular electrodes is designed and manufactured by taVNS AB in Saltsjö-Duvnäs, Sweden. Stimulation will be performed for 5 min twice daily for 12 weeks.

DEVICE

transauricular vagus nerve non-stimulation

TRAVAGUS is a portable electrical vagus nerve stimulator device that non-invasively activates the auricular branch of the vagus nerve in the left ear. The system consists of two units, the electrical stimulator and the ear electrodes that are mounted in a headset. The device is placed to the ear but no stimulation will occur. The procedure is performed for 5 min twice daily for 12 weeks.

Trial Locations (6)

17176

RECRUITING

Center for Rheumatology, Academic Specialist Centre, Stockholm

RECRUITING

Karolinska University Hospital, Stockholm

20502

RECRUITING

Section for Rheumatology, Skåne University Hospital, Malmö, Malmo

70116

RECRUITING

Dept of Rheumatology, Örebro University Hospital, Örebro

90189

RECRUITING

Dept of Rheumatology, Umeå University Hospital, Umeå

SE 22185

RECRUITING

Section for Rheumatology, Skåne University Hospital, Lund, Lund

All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

lead

taVNS AB

INDUSTRY