Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blind randomized controlled pilot trial.
Primary Purpose: Treatment
Masking: Single (Participant)
Masking Description: Participant will be blinded to which group they were randomized.

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator tcVNS Stimulation (Intervention)	Transcutaneous vagal nerve stimulation (tcVNS)	Device: 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 Comparator Sham tcVNS stimulation (Control)	Sham transcutaneous vagal nerve stimulation (Sham tcVNS)	Device: Sham (No Treatment) The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Northwestern University

Study Contact

Jordan Wood, BS
3126950915
jordan.wood1@northwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.