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Clinical Trials/NCT07610655
NCT07610655RecruitingNot Applicable

Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression

Northwestern University1 site in 1 country40 target enrollmentStarted: April 23, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participant will be blinded to which group they were randomized.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Aged > 18 years of age
  • •Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
  • •Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild
  • •Ability to use a keyboard
  • •Able to understand and communicate in English
  • •Be able to consent independently
  • •Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study.
  • •Must not be involved in any other research intervention study testing neurobehavioral functioning

Exclusion Criteria

  • •Age < 18 years of age
  • •History of vagotomy (cutting the vagus nerve)
  • •History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms
  • •History of seizure disorder or intracranial hemorrhage
  • •Patients with carotid stenosis
  • •Patients with aneurysms
  • •Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
  • •Pregnancy, breastfeeding
  • •Active addiction history
  • •ECG adhesive allergy
  • •Severe aphasia, preventing subject from understanding the protocol and giving written consent
  • •Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charles Hogue

James E. Eckenhoff Professor, Chair, Department of Anesthesiology

Northwestern University

Study Sites (1)

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