Transcutaneous Vagal Nerve Stimulation for Post-Surgical Recovery
This study is looking at whether a non-invasive device called transcutaneous vagal nerve stimulation (tcVNS) can help patients recover faster after lumbar surgery. The tcVNS device is placed on the ear and sends gentle electrical pulses to a nerve called the vagus nerve. Researchers want to see if tcVNS helps you wake up more quickly from anesthesia, leaves the recovery room (PACU) sooner, and reduces problems like delirium (confusion) and depression after surgery. You might be able to join if you are over 18, having lumbar surgery for degenerative disc disease or spinal stenosis, and can understand English. The study aims to enroll 40 participants and its current status is unclear.
- Study design
- This is an interventional study comparing transcutaneous vagal nerve stimulation (tcVNS) to a sham (no treatment) device, with a planned enrollment of 40 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures recovery of anesthesia at 24 hours, Richmond Agitation Sedation Scale (RASS Score) at 1 hour, and PACU discharge at 3 hours.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charles Hogue, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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What this trial measures
- Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia.24 Hours
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
- Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score)1 Hour
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.
- Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU)3 Hours
Admission time to the PACU to discharge from PACU in minutes elapsed.
- Aim 2: Primary Endpoint 2: Discharge from HospitalFrom PACU discharge (average of two hours post-surgical end time) to study completion (average of two days)
Time from Post Anesthesia Care Unit discharge to discharge from the hospital in days/minutes
- Aim 3: Primary Endpoint 1: Post Anesthesia Care Unit deliriumFrom PACU arrival to one hour post-PACU arrival
Comparison between active and sham tcVNS on delirium scores in the PACU at 30, 45 and 60 minutes after admission to the PACU. The 3D Confusion Assessment Method (3D CAM) will be administered at 30, 45 and 60 minutes after admission to PACU. The 3D CAM diagnostic tool scores delirium based on four core features, where Feature 1 (Acute Change) AND Feature 2 (Inattention) MUST be present, plus either Feature 3 (Disorganized Thinking) or Feature 4 (Altered Consciousness). It offers a severity score (3D-CAM-S) ranging from 0-20, with higher scores indicating more severe symptoms (0/20 low 20/20 high
- Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium30 Days after discharge
Delirium scores 30 days after discharge from the hospital. The 3D Confusion Assessment Method (3D CAM) will be administered 30 days after discharge from the hospital. The 3D CAM diagnostic tool scores delirium based on four core features, where Feature 1 (Acute Change) AND Feature 2 (Inattention) MUST be present, plus either Feature 3 (Disorganized Thinking) or Feature 4 (Altered Consciousness). It offers a severity score (3D-CAM-S) ranging from 0-20, with higher scores indicating more severe symptoms (0/20 low 20/20 high
- Aim3:Primary Endpoint 1b: PHQ-930 days
The Patient Health Questionnaire Nine (PHQ-9) is a 9-question survey used to measure patient depression potential, ranging 1-27 (1 low possibility of depression to 27 highest potential for depression. Tested at baseline, post operative day 1 and 30 days post discharge from hospital.