Microelectrode Recordings From the Vagus Nerve in Awake Humans

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2026

Conditions
Epilepsy
Interventions
OTHER

VNS stimulation and intraneural recordings

A minimum of three stimulation frequencies (1, 10 and 30 Hz), each up to 60s in duration, will be delivered via the VNS device. Intraneural recordings proximal or distal to the VNS electrodes during delivery of VNS will be performed. Approximately two to five fascicles will be explored in each nerve.

OTHER

Record multi-unit activity from intraneural sites

Perform a more detailed vagal nerve mapping study by recording from single nerve fibers, including those fibers supplying the heart, lungs, airways and other end-organs. The investigators shall perform functional mapping of the left and right vagus nerves, such as those with cardiac-related and/or respiratory-related neural activity. The research team will also record activity from other nearby fibers to map the differences in neurological behavior in fascicles that control the heart, lungs, airways and other systems.

Trial Locations (2)

3182

RECRUITING

99 Commercial Road, Prahan Victoria

55455

RECRUITING

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER