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

26. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Rekrutierung
        • Northwestern University Feinberg School of Medicine
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Charles Hogue, MD
        • Unterermittler:
          • Ravindra A Gupta, MD
        • Unterermittler:
          • John Bebawy, MD
        • Unterermittler:
          • Eyal Kimchi, MD, PhD
        • Unterermittler:
          • Jacqueline Morano, MD
        • Unterermittler:
          • Jamie Uejima, MD
        • Unterermittler:
          • Kimberly Klafta, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: tcVNS Stimulation (Intervention)
Transcutaneous vagal nerve stimulation (tcVNS)
Gerät: Transcutaneous vagal nerve stimulation
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.
Schein-Komparator: Sham tcVNS stimulation (Control)
Sham transcutaneous vagal nerve stimulation (Sham tcVNS)
Gerät: Sham (No Treatment)
The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia.
Zeitfenster: 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
24 Hours
Aim1:Primary Endpoint 2 : Richmond Agitation Sedation Scale (RASS Score)
Zeitfenster: 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.
1 Hour
Aim 2: Primary Endpoint 1: Post Anesthesia Care Unit Discharge (PACU)
Zeitfenster: 3 Hours
Admission time to the PACU to discharge from PACU in minutes elapsed.
3 Hours
Aim 2: Primary Endpoint 2: Discharge from Hospital
Zeitfenster: 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
From PACU discharge (average of two hours post-surgical end time) to study completion (average of two days)
Aim 3: Primary Endpoint 1: Post Anesthesia Care Unit delirium
Zeitfenster: 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
From PACU arrival to one hour post-PACU arrival
Aim 3: Primary Endpoint 1a: Post Anesthesia Care Delirium
Zeitfenster: 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
30 Days after discharge
Aim3:Primary Endpoint 1b: PHQ-9
Zeitfenster: 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.
30 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Aim 3: Secondary Endpoint 1:EEG Monitoring Data
Zeitfenster: 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
From pre-surgical EEG placement (i.e. approximately 30 minutes before surgery) through study completion (an average of 2 days)
The Montreal Cognitive Assessment (MoCA) evaluations
Zeitfenster: 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.
48 hours
SF-36 Survey
Zeitfenster: 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.
30 days
Neuro Qol Cognition Function Short Form
Zeitfenster: 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.
30 Days
Neuro- QOL
Zeitfenster: 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.
30 Days
DRS-R-98
Zeitfenster: 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.
48 hours
DigitSpan Test
Zeitfenster: 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.
48 Hours

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Northwestern University

Ermittler

  • Hauptermittler: Charles Hogue, MD, Northwestern University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. April 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Mai 2026

Zuerst gepostet (Tatsächlich)

28. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STU00223307

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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