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

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.

ClinicalTrials.gov IDNCT07610655

PhaseNA

Enrollment40

SponsorNorthwestern University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Post Operative Delirium, Cognitive Impairment, Vagus Nerve Stimulation, Depression

About this study

Interventions

Device: Transcutaneous vagal nerve stimulation — The tcVNS device utilized in this study is not an implanted device, but rather is solely operated outside of the body by affixing it around the patient's ear. The device delivers stimulation of the vagus nerve at designated intensity, interval, and frequency.
Device: Sham (No Treatment) — The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.

Primary outcomes

Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia. (24 Hours)
Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score) (1 Hour)
Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU) (3 Hours)
Aim 2: Primary Endpoint 2: Discharge from Hospital (From PACU discharge (average of two hours post-surgical end time) to study completion (average of two days))
Aim 3: Primary Endpoint 1: Post Anesthesia Care Unit delirium (From PACU arrival to one hour post-PACU arrival)
Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium (30 Days after discharge)
Aim3:Primary Endpoint 1b: PHQ-9 (30 days)

Eligibility information

Inclusion Criteria: 1. Aged \> 18 years of age 2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels 3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild 4. Ability to use a keyboard 5. Able to understand and communicate in English 6. Be able to consent independently 7. Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study. 8. Must not be involved in any other research intervention study testing neurobehavioral functioning Exclusion Criteria: 1. Age \< 18 years of age 2. History of vagotomy (cutting the vagus nerve) 3. 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 4. MoCA \< 18 5. History of seizure disorder or intracranial hemorrhage 6. Patients with carotid stenosis 7. Patients with aneurysms 8. Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability 9. Pregnancy, breastfeeding 10. Active addiction history 11. ECG adhesive allergy 12. Severe aphasia, preventing subject from understanding the protocol and giving written consent 13. Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.

Study locations

Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.