128
Participants
Start Date
March 21, 2025
Primary Completion Date
October 15, 2026
Study Completion Date
June 15, 2027
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.
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.
RECRUITING
Center for Rheumatology, Academic Specialist Centre, Stockholm
RECRUITING
Karolinska University Hospital, Stockholm
RECRUITING
Section for Rheumatology, Skåne University Hospital, Malmö, Malmo
RECRUITING
Dept of Rheumatology, Örebro University Hospital, Örebro
RECRUITING
Dept of Rheumatology, Umeå University Hospital, Umeå
RECRUITING
Section for Rheumatology, Skåne University Hospital, Lund, Lund
Karolinska Institutet
OTHER
taVNS AB
INDUSTRY