Cognitive Impairment, Depression, Post Operative Delirium, Vagus Nerve Stimulation
Conditions
Keywords
Anesthesia Care, Post Anesthesia Care, Post Surgical Care, Vagus Nerve Stimulation, Delirium, Cognitive Imparment, Depression, Hospital Length of Stay
Brief summary
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.
Interventions
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.
DEVICESham (No Treatment)
The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will be blinded to which group they were randomized.
Intervention model description
Single blind randomized controlled pilot trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged \> 18 years of age 2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels 3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild 4. Ability to use a keyboard 5. Able to understand and communicate in English 6. Be able to consent independently 7. Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study. 8. Must not be involved in any other research intervention study testing neurobehavioral functioning
Exclusion criteria
1. Age \< 18 years of age 2. History of vagotomy (cutting the vagus nerve) 3. 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 4. MoCA \< 18 5. History of seizure disorder or intracranial hemorrhage 6. Patients with carotid stenosis 7. Patients with aneurysms 8. Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability 9. Pregnancy, breastfeeding 10. Active addiction history 11. ECG adhesive allergy 12. Severe aphasia, preventing subject from understanding the protocol and giving written consent 13. Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Hospital | From 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 delirium | From 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 Delirium | 30 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-9 | 30 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aim 3: Secondary Endpoint 1:EEG Monitoring Data | From pre-surgical EEG placement (i.e. approximately 30 minutes before surgery) through study completion (an average of 2 days) | 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 |
| The Montreal Cognitive Assessment (MoCA) evaluations | 48 hours | 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. |
| SF-36 Survey | 30 days | 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. |
| Neuro Qol Cognition Function Short Form | 30 Days | 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. |
| Neuro- QOL | 30 Days | Neuro-QoL(Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults who may have neurological conditions. Tested at baseline and 30 days. |
| DRS-R-98 | 48 hours | The Delirium Rating Scale (DRS-R-98) is a tool for assessing symptom severity and diagnosing delirium in clinical settings. This sixteen-item scale in a thirteen-item severity section and three diagnostic items, tracking changes over a twenty-four-hour period. The 16-item, clinician-rated tool used to diagnose and measure the severity of delirium. It consists of 13 severity items (scored 0-3) and 3 diagnostic items (scored 0-2 or 0-3), with a maximum total score of 46. Higher scores indicate more severe delirium, with scores of15 or greater than or greater than 17.5 often indicating delirium. Assessed at Day 1 and day 2 post operative. |
| DigitSpan Test | 48 Hours | Digit Span test measures auditory short-term memory and working memory capacity by asking participants to repeat sequences of digits in forward, reversed, or ordered sequences. It is used to measure cognitive processing, attention, and executive function, usually contains 5-9 digits. scoring typically awards one point for each correctly repeated sequence. Performed post operative day 1and 2. |
Countries
United States
Contacts
CONTACTJordan Wood, BS
PRINCIPAL_INVESTIGATORCharles Hogue, MD
Northwestern University
Outcome results
None listed