Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression (tVNS)
26. mai 2026 oppdatert av: Charles Hogue, Northwestern University
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jordan Wood, BS
- Telefonnummer: 3126950915
- E-post: jordan.wood1@northwestern.edu
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Rekruttering
- Northwestern University Feinberg School of Medicine
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Ta kontakt med:
- Jordan Wood, BS
- Telefonnummer: 312-695-0915
- E-post: jordan.wood1@northwestern.edu
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Ta kontakt med:
- Bin Zhang, MS
- Telefonnummer: 312-695-7771
- E-post: bin.zhang1@northwestern.edu
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Hovedetterforsker:
- Charles Hogue, MD
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Underetterforsker:
- Ravindra A Gupta, MD
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Underetterforsker:
- John Bebawy, MD
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Underetterforsker:
- Eyal Kimchi, MD, PhD
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Underetterforsker:
- Jacqueline Morano, MD
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Underetterforsker:
- Jamie Uejima, MD
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Underetterforsker:
- Kimberly Klafta, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
- 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
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
- MoCA < 18
- 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 will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: tcVNS Stimulation (Intervention)
Transcutaneous vagal nerve stimulation (tcVNS)
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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.
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Sham-komparator: Sham tcVNS stimulation (Control)
Sham transcutaneous vagal nerve stimulation (Sham tcVNS)
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The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia.
Tidsramme: 24 Hours
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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
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24 Hours
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Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score)
Tidsramme: 1 Hour
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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.
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1 Hour
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Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU)
Tidsramme: 3 Hours
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Admission time to the PACU to discharge from PACU in minutes elapsed.
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3 Hours
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Aim 2: Primary Endpoint 2: Discharge from Hospital
Tidsramme: From PACU discharge (average of two hours post-surgical end time) to study completion (average of two days)
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Time from Post Anesthesia Care Unit discharge to discharge from the hospital in days/minutes
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From PACU discharge (average of two hours post-surgical end time) to study completion (average of two days)
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Aim 3: Primary Endpoint 1: Post Anesthesia Care Unit delirium
Tidsramme: From PACU arrival to one hour post-PACU arrival
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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
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From PACU arrival to one hour post-PACU arrival
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Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium
Tidsramme: 30 Days after discharge
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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
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30 Days after discharge
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Aim3:Primary Endpoint 1b: PHQ-9
Tidsramme: 30 days
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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.
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30 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Aim 3: Secondary Endpoint 1:EEG Monitoring Data
Tidsramme: From pre-surgical EEG placement (i.e. approximately 30 minutes before surgery) through study completion (an average of 2 days)
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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
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From pre-surgical EEG placement (i.e. approximately 30 minutes before surgery) through study completion (an average of 2 days)
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The Montreal Cognitive Assessment (MoCA) evaluations
Tidsramme: 48 hours
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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.
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48 hours
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SF-36 Survey
Tidsramme: 30 days
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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.
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30 days
|
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Neuro Qol Cognition Function Short Form
Tidsramme: 30 Days
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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.
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30 Days
|
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Neuro- QOL
Tidsramme: 30 Days
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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.
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30 Days
|
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DRS-R-98
Tidsramme: 48 hours
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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.
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48 hours
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DigitSpan Test
Tidsramme: 48 Hours
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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.
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48 Hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Charles Hogue, MD, Northwestern University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
- Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
- George MS, Aston-Jones G. Noninvasive techniques for probing neurocircuitry and treating illness: vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Neuropsychopharmacology. 2010 Jan;35(1):301-16. doi: 10.1038/npp.2009.87.
- Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.
- Gershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, Miller D, Peterman A, Cella D. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012 Apr;21(3):475-86. doi: 10.1007/s11136-011-9958-8. Epub 2011 Aug 27.
- Ruffoli R, Giorgi FS, Pizzanelli C, Murri L, Paparelli A, Fornai F. The chemical neuroanatomy of vagus nerve stimulation. J Chem Neuroanat. 2011 Dec;42(4):288-96. doi: 10.1016/j.jchemneu.2010.12.002. Epub 2010 Dec 16.
- Assenza G, Tombini M, Lanzone J, Ricci L, Di Lazzaro V, Casciato S, Morano A, Giallonardo AT, Di Bonaventura C, Beghi E, Ferlazzo E, Gasparini S, Giuliano L, Pisani F, Benna P, Bisulli F, De Falco FA, Franceschetti S, La Neve A, Meletti S, Mostacci B, Sartucci F, Striano P, Villani F, Aguglia U, Avanzini G, Belcastro V, Bianchi A, Cianci V, Labate A, Magaudda A, Michelucci R, Verri A, Zaccara G, Pizza V, Tinuper P, Di Gennaro G; Epilepsy Study Group of the Italian Neurological Society. Antidepressant effect of vagal nerve stimulation in epilepsy patients: a systematic review. Neurol Sci. 2020 Nov;41(11):3075-3084. doi: 10.1007/s10072-020-04479-2. Epub 2020 Jun 10.
- Han S, Kim M, Kim H, Shin H, Youn I. Ketamine Inhibits Ultrasound Stimulation-Induced Neuromodulation by Blocking Cortical Neuron Activity. Ultrasound Med Biol. 2018 Mar;44(3):635-646. doi: 10.1016/j.ultrasmedbio.2017.11.008. Epub 2017 Dec 21.
- Hachem LD, Wong SM, Ibrahim GM. The vagus afferent network: emerging role in translational connectomics. Neurosurg Focus. 2018 Sep;45(3):E2. doi: 10.3171/2018.6.FOCUS18216.
- Rufener KS, Geyer U, Janitzky K, Heinze HJ, Zaehle T. Modulating auditory selective attention by non-invasive brain stimulation: Differential effects of transcutaneous vagal nerve stimulation and transcranial random noise stimulation. Eur J Neurosci. 2018 Sep;48(6):2301-2309. doi: 10.1111/ejn.14128. Epub 2018 Sep 9.
- Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
- Simon SE, Bergmann MA, Jones RN, Murphy KM, Orav EJ, Marcantonio ER. Reliability of a structured assessment for nonclinicians to detect delirium among new admissions to postacute care. J Am Med Dir Assoc. 2006 Sep;7(7):412-5. doi: 10.1016/j.jamda.2006.02.006. Epub 2006 May 30.
- Gusmao-Flores D, Salluh JI, Chalhub RA, Quarantini LC. The confusion assessment method for the intensive care unit (CAM-ICU) and intensive care delirium screening checklist (ICDSC) for the diagnosis of delirium: a systematic review and meta-analysis of clinical studies. Crit Care. 2012 Jul 3;16(4):R115. doi: 10.1186/cc11407.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. april 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. mai 2029
Datoer for studieregistrering
Først innsendt
13. mai 2026
Først innsendt som oppfylte QC-kriteriene
26. mai 2026
Først lagt ut (Faktiske)
28. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Atferdssymptomer
- Forvirring
- Nevroatferdsmanifestasjoner
- Nevrokognitive lidelser
- Kognisjonsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Emergence Delirium
- Delirium
- Kognitiv dysfunksjon
- Depresjon
Andre studie-ID-numre
- STU00223307
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .