Noninvasive Transcutaneous Vagal Nerve Stimulation (tcVNS) for Neuromodulating the Conscious State

NCT ID: NCT07191340

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2023-11-30

Brief Summary

The purpose of this study is to examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) (Gammacore Sapphire Device) can help restore consciousness in patients in the Operating Room and Post Anesthesia Care Unit (PACU). To examine whether tcVNS administered in the PACU can help reduce delirium and depression post-surgery, speeding up cognitive recovery from anesthesia, and finally determine if tcVNS can expedite discharge from the PACU.

Conditions

Anesthesia; Delirium; Depression; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group Stimulation of Vagus Nerve

Stimulation of the vagus nerve with nerve stimulator placed on neck

Group Type: ACTIVE_COMPARATOR

Vagus nerve stimulator

Intervention Type: DEVICE

Vagus nerve stimulator placed on neck and activated

Sham Placebo Group No Stimulation to Vagus Nerve

Nerve stimulator placed on neck but not activated.

Group Type: PLACEBO_COMPARATOR

Placebo comparator sham

Intervention Type: DEVICE

Vagus nerve stimulator placed on neck and not activated

Interventions

Vagus nerve stimulator

Vagus nerve stimulator placed on neck and activated

Intervention Type: DEVICE

Placebo comparator sham

Vagus nerve stimulator placed on neck and not activated

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged > 18 years of age
• Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
• Mini-Mental State Examination (MMSE) score ≥ 15-accept mild
• Ability to use a keyboard
• Able to understand and communicate in English
• Be able to consent independently
• Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study.
• Must not be involved in any other research intervention study testing neurobehavioral functioning
• Good internet connectivity and ability to use computer, smart phone or good telephone connectivity (follow up)

Exclusion Criteria

• Age < 18 years of age
• History of vagotomy (cutting the vagus nerve)
• 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
• MMSE < 15
• History of seizure disorder or intracranial hemorrhage
• Patients with carotid stenosis
• Patients with aneurysms
• Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
• Pregnancy, breastfeeding
• Active addiction history
• ECG adhesive allergy
• Severe aphasia, preventing subject from understanding the protocol and giving written consent
• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck
• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck
• Patients who are using another device at the same time (e.g., transcutaneous electrical nerve stimulation (TENS) Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alyson Engle, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Univesity

Other Identifiers

STU00217188

Identifier Type: -

Identifier Source: org_study_id