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

NCT07610655 | Recruiting DMC FDA Device

• 1 other identifier: STU00223307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anesthesia Care; Post Anesthesia Care; Post Surgical Care; Vagus Nerve Stimulation; Delirium; Cognitive Imparment; Depression; Hospital Length of Stay

Outcome Measures

Primary Outcomes (7)

• Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia.

  Time in minutes to a Patient State Index (PSI) (Sedline Sedation Monitor) score of 85. The PSI is a quantitative score derived from 4 channel EEG monitoring of the frontal and prefrontal cortex for assessing level of consciousnes during sedation and general anesthesia. The score ranges from 0 (EEG supression) -100 (fully awake). A PSI range of 25-50 indicates optimal hypnotic state for general anesthesia

  24 Hours

• Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score)

  The Richmond Agitation-Sedation Scale (RASS) is a 10-point validated scale used to measure patient sedation levels in post-anesthesia care unit, ranging from +4 (combative) to -5 (unarousable). A score of 0 is "alert and calm".Measured on arrival to PACU then at 10,15,30,45,60 minutes after admission to PACU.

  1 Hour

• Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU)

  Admission time to the PACU to discharge from PACU in minutes elapsed.

  3 Hours

• Aim 2: Primary Endpoint 2: Discharge from Hospital

  Time from Post Anesthesia Care Unit discharge to discharge from the hospital in days/minutes

  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

  Comparison between active and sham tcVNS on delirium scores in the PACU at 30, 45 and 60 minutes after admission to the PACU. The 3D Confusion Assessment Method (3D CAM) will be administered at 30, 45 and 60 minutes after admission to PACU. The 3D CAM diagnostic tool scores delirium based on four core features, where Feature 1 (Acute Change) AND Feature 2 (Inattention) MUST be present, plus either Feature 3 (Disorganized Thinking) or Feature 4 (Altered Consciousness). It offers a severity score (3D-CAM-S) ranging from 0-20, with higher scores indicating more severe symptoms (0/20 low 20/20 high

  From PACU arrival to one hour post-PACU arrival

• Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium

  Delirium scores 30 days after discharge from the hospital. The 3D Confusion Assessment Method (3D CAM) will be administered 30 days after discharge from the hospital. The 3D CAM diagnostic tool scores delirium based on four core features, where Feature 1 (Acute Change) AND Feature 2 (Inattention) MUST be present, plus either Feature 3 (Disorganized Thinking) or Feature 4 (Altered Consciousness). It offers a severity score (3D-CAM-S) ranging from 0-20, with higher scores indicating more severe symptoms (0/20 low 20/20 high

  30 Days after discharge

• Aim3:Primary Endpoint 1b: PHQ-9

  The Patient Health Questionnaire Nine (PHQ-9) is a 9-question survey used to measure patient depression potential, ranging 1-27 (1 low possibility of depression to 27 highest potential for depression. Tested at baseline, post operative day 1 and 30 days post discharge from hospital.

  30 days

Secondary Outcomes (7)

• Aim 3: Secondary Endpoint 1:EEG Monitoring Data

  From pre-surgical EEG placement (i.e. approximately 30 minutes before surgery) through study completion (an average of 2 days)

• The Montreal Cognitive Assessment (MoCA) evaluations

  48 hours

• SF-36 Survey

  30 days

• Neuro Qol Cognition Function Short Form

  30 Days

• Neuro- QOL

  30 Days

Study Arms (2)

tcVNS Stimulation (Intervention)

ACTIVE COMPARATOR

Transcutaneous vagal nerve stimulation (tcVNS)

Device: Transcutaneous vagal nerve stimulation

Sham tcVNS stimulation (Control)

SHAM COMPARATOR

Sham transcutaneous vagal nerve stimulation (Sham tcVNS)

Device: Sham (No Treatment)

Interventions

Transcutaneous vagal nerve stimulation DEVICE

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.

tcVNS Stimulation (Intervention)

Sham (No Treatment) DEVICE

The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.

Sham tcVNS stimulation (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• MoCA \< 18
• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (14)

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• Hachem LD, Wong SM, Ibrahim GM. The vagus afferent network: emerging role in translational connectomics. Neurosurg Focus. 2018 Sep;45(3):E2. doi: 10.3171/2018.6.FOCUS18216.

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• Rufener KS, Geyer U, Janitzky K, Heinze HJ, Zaehle T. Modulating auditory selective attention by non-invasive brain stimulation: Differential effects of transcutaneous vagal nerve stimulation and transcranial random noise stimulation. Eur J Neurosci. 2018 Sep;48(6):2301-2309. doi: 10.1111/ejn.14128. Epub 2018 Sep 9.

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MeSH Terms

Conditions

Emergence Delirium; Cognitive Dysfunction; Depression; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• Charles Hogue, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Wood, BS

CONTACT

3126950915; jordan.wood1@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to which group they were randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James E. Eckenhoff Professor, Chair, Department of Anesthesiology

Model Details: Single blind randomized controlled pilot trial.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 28, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)