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

NCT07191340 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-09-24

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Alyson Engle, MD · Northwestern Univesity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-10-31
Completion
2023-11-30
FDA Device
Yes

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191340 on ClinicalTrials.gov