Recruiting

tcVNS

Sponsor:

Northwestern University

Code:

NCT07610655

Conditions

Post Operative Delirium

Cognitive Impairment

Vagus Nerve Stimulation

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous vagal nerve stimulation

Sham (No Treatment)

Study Details

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

Study ID

NCT07610655

Start date

Apr 23, 2026

Status verified date

May, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: tcVNS Stimulation (Intervention)

Transcutaneous vagal nerve stimulation (tcVNS)

sham comparator: Sham tcVNS stimulation (Control)

Sham transcutaneous vagal nerve stimulation (Sham tcVNS)

Interventions

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.

Sham (No Treatment)

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

Primary outcome measure

  • Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia. [ Time Frame: 24 Hours ]
  • Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score) [ Time Frame: 1 Hour ]
  • Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU) [ Time Frame: 3 Hours ]
  • 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) ]
  • Aim 3: Primary Endpoint 1: Post Anesthesia Care Unit delirium [ Time Frame: From PACU arrival to one hour post-PACU arrival ]
  • Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium [ Time Frame: 30 Days after discharge ]
  • Aim3:Primary Endpoint 1b: PHQ-9 [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Charles Hogue, MD

More Information

Sponsor

Northwestern University

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-28.