NCT07191340

Noninvasive Transcutaneous Vagal Nerve Stimulation (tcVNS) for Neuromodulating the Conscious State

A Prospective, Randomized, Single-Blinded, Crossover Clinical Trial Evaluating the Use of Noninvasive Transcutaneous Vagal Nerve Stimulation (tcVNS) for Neuromodulating the Conscious State

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) (Gammacore Sapphire Device) can help restore consciousness in patients in the Operating Room and Post Anesthesia Care Unit (PACU). To examine whether tcVNS administered in the PACU can help reduce delirium and depression post-surgery, speeding up cognitive recovery from anesthesia, and finally determine if tcVNS can expedite discharge from the PACU.

Conditions

• Anesthesia
• Delirium
• Depression
• Cognitive Function

Interventions

Type	Name	Description
DEVICE	Vagus nerve stimulator	Vagus nerve stimulator placed on neck and activated
DEVICE	Placebo comparator sham	Vagus nerve stimulator placed on neck and not activated

Timeline

• Start date: 2023-10-01
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2025-09-24
• Last updated: 2025-09-24

Regulatory

• FDA-regulated device study