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

Northwestern University

Status: Enrolling

Conditions: Post Operative Delirium; Cognitive Impairment; Vagus Nerve Stimulation; Depression

Treatments: Device: Sham (No Treatment); Device: Transcutaneous vagal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07610655

STU00223307

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

tcVNS Stimulation (Intervention)

Active Comparator group

Description:

Transcutaneous vagal nerve stimulation (tcVNS)

Treatment:

Device: Transcutaneous vagal nerve stimulation

Sham tcVNS stimulation (Control)

Sham Comparator group

Description:

Sham transcutaneous vagal nerve stimulation (Sham tcVNS)

Treatment:

Device: Sham (No Treatment)