Effects of Transcutaneous Vagal Nerve Stimulation on Return to Consciousness After Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will evaluate the effect of transcutaneous vagal nerve stimulation (tcVNS) versus sham on patients undergoing lumbar surgery for degenerative disease or spinal stenosis. The aim is to see if tcVNS facilitates emergence from anesthesia, speeds recovery in the PACU, and lowers delirium and depressive symptoms after surgery. Participants must be adults with adequate cognitive function (MoCA ≥ 18) and be able to consent and use a keyboard; electrical stimulation will be compared to a sham condition. The trial will be conducted at Northwestern University Feinberg School of Medicine, led by Northwestern University with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Northwestern University Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Charles Hogue, MD — Northwestern University
• Study coordinator: Jordan Wood, BS
• Email: jordan.wood1@northwestern.edu
• Phone: 3126950915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.