Blinding and Adverse Effects of Ultrasonic Vagus Nerve Stimulation (U-VNS)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 10, 2024

Primary Completion Date

February 28, 2025

Study Completion Date

June 28, 2025

Conditions
U-VNSSham U-VNS
Interventions
DEVICE

Ultrasound Vagus Nerve Stimulation (U-VNS)

Ultrasound stimulation of the auricular branch of the vagus nerve using the ZenBud device manufactured by NeurGear (Rochester, New York, USA), a CE-compliant over-the-ear headset. It delivers low-intensity focused ultrasound to the auricular branch of the vagus nerve through several layers of skin (centre frequency 5.3 MHz, pulse repetition rate 41 hertz, 50% duty cycle, average intensity of 1.03 MPa).

DEVICE

Sham U-VNS

Sham device, also produced by NeurGear, which is identical in appearance to the true ZenBud device, emits the same sound and warms up slightly where the transducer sits on the skin.

Trial Locations (1)

NG1 5DU

NIHR Nottingham BRC Hearing Theme, Nottingham

All Listed Sponsors
lead

University of Nottingham

OTHER

NCT07091812 - Blinding and Adverse Effects of Ultrasonic Vagus Nerve Stimulation (U-VNS) | Biotech Hunter | Biotech Hunter