13
Participants
Start Date
July 8, 2022
Primary Completion Date
December 31, 2026
Study Completion Date
July 31, 2028
Vagus Nerve Stimulator
The device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating/recording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control/Review Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on/off the system and perform limited adjustment of the stimulation strategy).
RECRUITING
Austin Health, Melbourne
Lead Sponsor
Florey Institute of Neuroscience and Mental Health
UNKNOWN
University of Melbourne
OTHER
The Bionics Institute of Australia
OTHER
University of Queensland Diamantina Institute
UNKNOWN
Austin Health
OTHER_GOV