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Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression

Sponsored by Northwestern University

About this study

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.

Where this study is enrolling

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.