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

ConditionsPost Operative DeliriumCognitive ImpairmentVagus Nerve StimulationDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged > 18 years of age

Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels

Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild

Ability to use a keyboard

Disqualifiers

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

MoCA < 18

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous vagal nerve stimulation

    Device

    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 (No Treatment)

    Device

    The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: tcVNS Stimulation (Intervention)Active comparator 1 intervention
Group B: Sham tcVNS stimulation (Control)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia.

Time in minutes to a Patient State Index (PSI) (Sedline Sedation Monitor) 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 consciousnes during sedation and general anesthesia. The score ranges from 0 (EEG supression) -100 (fully awake). A PSI range of 25-50 indicates optimal hypnotic state for general anesthesia

Time frame
24 Hours
2

Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score)

The Richmond Agitation-Sedation Scale (RASS) is a 10-point validated scale used to measure patient sedation levels in post-anesthesia care unit, ranging from +4 (combative) to -5 (unarousable). A score of 0 is "alert and calm".Measured on arrival to PACU then at 10,15,30,45,60 minutes after admission to PACU.

Time frame
1 Hour
3

Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU)

Admission time to the PACU to discharge from PACU in minutes elapsed.

Time frame
3 Hours
4

Aim 2: Primary Endpoint 2: Discharge from Hospital

Time from Post Anesthesia Care Unit discharge to discharge from the hospital in days/minutes

Time frame
From PACU discharge (average of two hours post-surgical end time) to study completion (average of two days)

Secondary outcomes

1

Aim 3: Secondary Endpoint 1:EEG Monitoring Data

Continuous EEG monitoring data to be evaluated for patterns associated with delirium (polymorphiic delta waves, generalized slowing quantified as delta range vs alpha range power

Time frame
From pre-surgical EEG placement (i.e. approximately 30 minutes before surgery) through study completion (an average of 2 days)
2

The Montreal Cognitive Assessment (MoCA) evaluations

The MoCA includes measures of memory recll, visuospatial processing, executive functions, attention, language, abstract reasoning and orientation to time and place. Administered baseline and post operative day 2. 0-30 point scale, 26 and above is normal, 18-25 mild cognitive dysfunction, 10-17 is moderate dysfunction and 0-10 is severe dysfunction.

Time frame
48 hours
3

SF-36 Survey

The 36-Item Short Form Survey (SF-36) is a self-reported patient outcome measure that assesses physical and mental health across eight domains, including functioning, pain, and vitality. Score ranges from 0 low to 100 high. The higher the score the better the overall health. Administered at baseline and 30 days after discharge.

Time frame
30 days
4

Neuro Qol Cognition Function Short Form

This is a brief self-report tool used to measure perceived difficulties in everyday cognitive tasks. It is a portion of of the Quality of Life in Neurological Disorders (Neuro-QoL). he short form uses T-scores, which standardize results against a reference population (typically the U.S. general population).There are 8 questions. A T-score of 50 represents the average for the reference population. A high score indicates better perceived cognitive function. Completed at baseline and 30 days.

Time frame
30 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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