Actively Recruiting
Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
Led by Northwestern University · Updated on 2026-05-28
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether noninvasive transcutaneous vagal nerve stimulation (tcVNS) can help patients wake up more quickly after surgery and anesthesia. The study focuses on patients in the operating room and the Post Anesthesia Care Unit (PACU), examining if tcVNS can speed discharge from the PACU and reduce delirium and depression after surgery. The effects of tcVNS on cognitive recovery following anesthesia are also being evaluated. Participants will be randomly assigned to receive either active tcVNS or a sham (inactive) stimulation device. The tcVNS device is applied outside the body around the ear to stimulate the vagus nerve with specific intensity and frequency. The sham device is applied similarly but does not deliver stimulation. Treatment is given during the surgical recovery period, including the PACU. During the study, participants will have various assessments including EEG monitoring from before surgery through recovery, cognitive tests such as the Montreal Cognitive Assessment, and surveys measuring quality of life and mood up to 30 days after surgery. Researchers will track recovery speed using sedation scales and discharge timing, and monitor for delirium and depression. Safety and cognitive function will be closely evaluated throughout the study period, which lasts about two days with follow-up assessments up to 30 days after surgery.
CONDITIONS
Brief Title
Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years
- Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
- Montreal Cognitive Assessment (MoCA) score of 18 or higher
- Ability to use a keyboard
- Able to understand and communicate in English
- Able to provide independent consent
- Women of child-bearing age comfortable confirming a negative pregnancy test prior to participation
- Not currently involved in other research studies testing neurobehavioral function
You will not qualify if you...
- Under 18 years of age
- History of vagotomy (cutting the vagus nerve)
- History of heart conditions including bradycardia, heart block, prolonged QT syndrome, Brugada syndrome, heart failure with ejection fraction less than 35%, or New York Heart Association symptoms
- Montreal Cognitive Assessment (MoCA) score below 18
- History of seizure disorder or intracranial hemorrhage
- Presence of carotid stenosis
- Presence of aneurysms
- Other neurological diagnoses or severe psychiatric disorders such as psychosis or childhood learning disabilities
- Pregnancy or breastfeeding
- Active addiction history
- Allergy to ECG adhesives
- Severe aphasia preventing understanding of the protocol and consent
- Postoperative neck swelling at the site of left tcVNS application
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 days
Participants receive transcutaneous vagal nerve stimulation or sham stimulation around the ear to assess effects on post-surgical recovery.
Visits occur from approximately 30 minutes before surgery through hospital discharge over about 2 days
Duration - 30 days
Participants are monitored for recovery, delirium, depression, and cognitive function after hospital discharge.
1 visit at 30 days post-discharge
Trial Site Locations
Total: 1 location
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
J
Jordan Wood, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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