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

NCT07191340 | Withdrawn DMC FDA Device

• 1 other identifier: STU00217188
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Vagal Nerve Stimulator; Post Anesthesia Care; Post Surgical

Outcome Measures

Primary Outcomes (2)

• Aim 1: To determine if administering tcVNS enhances recovery from anesthesia

  Time to a Patient State Index™ (PSi, Sedline Sedation Monitor, Massimo, Inc, Irvine, CA) score of 85.The PSi is a quantitative score derived from 4 channel EEG monitoring of the frontal and prefrontal cortex for assessing level of consciousness during sedation and general anesthesia. The score ranges from 0 (EEG suppression) to 100 (fully awake). A PSi range of 25-50 indicates optimal hypnotic state for general anesthesia.

  60 minutes

• To determine if administering tcVNS improves Richmond Agitation-Sedation Scale (RASS) scores after anesthesia

  RASS Score on arrival to the PACU then 10, 15, 30, 45 and 60 min later.The Richmond Agitation-Sedation Scale (RASS) is a standardized instrument to assess arousal, cognition, and sustainability to stepped progression of stimuli. The patient is first observed. If alert a score between 1 to 4 is assigned based on their cognitive state. If the patient is not alert, the patient's name is loudly spoken and they are instructed to open their eyes and look at the speaker. This is repeated once if necessary. If there is eye opening and eye contact for \> 10 seconds, a score of -1 is assigned. If not sustained for 10 secs then a score of -2 is assigned, and so forth.

  60 minutes

Secondary Outcomes (1)

• To determine if tcVNS can improve conscious cognitive control in post-surgical patients.

  1 month after surgery

Study Arms (2)

Treatment Group Stimulation of Vagus Nerve

ACTIVE COMPARATOR

Stimulation of the vagus nerve with nerve stimulator placed on neck

Device: Vagus nerve stimulator

Sham Placebo Group No Stimulation to Vagus Nerve

PLACEBO COMPARATOR

Nerve stimulator placed on neck but not activated.

Device: Placebo comparator sham

Interventions

Vagus nerve stimulator DEVICE

Vagus nerve stimulator placed on neck and activated

Treatment Group Stimulation of Vagus Nerve

Placebo comparator sham DEVICE

Vagus nerve stimulator placed on neck and not activated

Sham Placebo Group No Stimulation to Vagus Nerve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Delirium; Depression

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alyson Engle, MD

  Northwestern Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and outcomes assessor will not know which treatment arm the subject has been assigned to during the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: September 24, 2025
• Study Start: October 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 24, 2025

Record last verified: 2025-09