NCT07610655NARecruiting
Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
Northwestern University
Start Date
4/23/2026
Completion Date
5/31/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Transcutaneous vagal nerve stimulation
DEVICE
Sham (No Treatment)
Conditions
Post Operative DeliriumCognitive ImpairmentVagus Nerve StimulationDepression
Locations
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States