Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07610655

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Bin Zhang, MS

CONTACT

[email protected]

312-695-7771

Charles Hogue, MD

PRINCIPAL_INVESTIGATOR

Eyal Kimchi, MD, PhD

SUB_INVESTIGATOR

Jacqueline Morano, MD

SUB_INVESTIGATOR

Jamie Uejima, MD

SUB_INVESTIGATOR

John Bebawy, MD

SUB_INVESTIGATOR

Jordan Wood, BS

CONTACT

[email protected]

312-695-0915

Kimberly Klafta, MD

SUB_INVESTIGATOR

Ravindra A Gupta, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

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.

Sham (No Treatment)

Device

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

Primary outcomes

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

    Time frame: 24 Hours

    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

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

    Time frame: 1 Hour

    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.

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

    Time frame: 3 Hours

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

  4. Aim 2: Primary Endpoint 2: Discharge from Hospital

    Time frame: From PACU discharge (average of two hours post-surgical end time) to study completion (average of two days)

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

  5. Aim 3: Primary Endpoint 1: Post Anesthesia Care Unit delirium

    Time frame: From PACU arrival to one hour post-PACU arrival

    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

  6. Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium

    Time frame: 30 Days after discharge

    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

  7. Aim3:Primary Endpoint 1b: PHQ-9

    Time frame: 30 days

    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.

Secondary outcomes

  1. Aim 3: Secondary Endpoint 1:EEG Monitoring Data

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

    Continuous EEG monitoring data to be evaluated for patterns associated with delirium (polymorphiic delta waves, generalized slowing quantified as delta range vs alpha range power

  2. The Montreal Cognitive Assessment (MoCA) evaluations

    Time frame: 48 hours

    The MoCA includes measures of memory recll, visuospatial processing, executive functions, attention, language, abstract reasoning and orientation to time and place. Administered baseline and post operative day 2. 0-30 point scale, 26 and above is normal, 18-25 mild cognitive dysfunction, 10-17 is moderate dysfunction and 0-10 is severe dysfunction.

  3. SF-36 Survey

    Time frame: 30 days

    The 36-Item Short Form Survey (SF-36) is a self-reported patient outcome measure that assesses physical and mental health across eight domains, including functioning, pain, and vitality. Score ranges from 0 low to 100 high. The higher the score the better the overall health. Administered at baseline and 30 days after discharge.

  4. Neuro Qol Cognition Function Short Form

    Time frame: 30 Days

    This is a brief self-report tool used to measure perceived difficulties in everyday cognitive tasks. It is a portion of of the Quality of Life in Neurological Disorders (Neuro-QoL). he short form uses T-scores, which standardize results against a reference population (typically the U.S. general population).There are 8 questions. A T-score of 50 represents the average for the reference population. A high score indicates better perceived cognitive function. Completed at baseline and 30 days.

  5. Neuro- QOL

    Time frame: 30 Days

    Neuro-QoL(Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults who may have neurological conditions. Tested at baseline and 30 days.

  6. DRS-R-98

    Time frame: 48 hours

    The Delirium Rating Scale (DRS-R-98) is a tool for assessing symptom severity and diagnosing delirium in clinical settings. This sixteen-item scale in a thirteen-item severity section and three diagnostic items, tracking changes over a twenty-four-hour period. The 16-item, clinician-rated tool used to diagnose and measure the severity of delirium. It consists of 13 severity items (scored 0-3) and 3 diagnostic items (scored 0-2 or 0-3), with a maximum total score of 46. Higher scores indicate more severe delirium, with scores of15 or greater than or greater than 17.5 often indicating delirium. Assessed at Day 1 and day 2 post operative.

  7. DigitSpan Test

    Time frame: 48 Hours

    Digit Span test measures auditory short-term memory and working memory capacity by asking participants to repeat sequences of digits in forward, reversed, or ordered sequences. It is used to measure cognitive processing, attention, and executive function, usually contains 5-9 digits. scoring typically awards one point for each correctly repeated sequence. Performed post operative day 1and 2.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Wood, BS

CONTACT

[email protected]

3126950915

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: tVNS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.