The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis

NARecruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

December 31, 2031

Conditions
Arthritis, Rheumatoid
Interventions
DEVICE

abdominal vagus nerve stimulation (aVNS)

Participants will receive aVNS, delivered by a commercially available stimulator placed under the skin, and a custom-designed electrode array attached to the abdominal vagus nerve. Stimulation will commence 2 weeks after laparoscopic surgical implantation of the device, and occur daily for 22-weeks stimulation in the initial phase of the study.

Trial Locations (3)

3065

RECRUITING

Bionics Institute, Fitzroy

RECRUITING

St Vincent's Hospital, Department of Rheumatology, Fitzroy

3079

RECRUITING

Austin Health, Heidelberg Repatriation Hospital, Ivanhoe

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

St Vincent's Hospital Melbourne

OTHER

collaborator

Austin Health

OTHER_GOV

lead

The Bionics Institute of Australia

OTHER