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

Northwestern University

Status

Withdrawn

Conditions

Cognitive Function

Delirium

Depression

Anesthesia

Treatments

Device: Vagus nerve stimulator

Device: Placebo comparator sham

Study type

Interventional

Funder types

Other

Identifiers

NCT07191340

STU00217188

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).