Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression (tVNS)
2026年5月26日 更新者：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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jordan Wood, BS
- 電話番号：3126950915
- メール：jordan.wood1@northwestern.edu
研究場所
-
-
Illinois
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Chicago、Illinois、アメリカ、60611
- 募集
- Northwestern University Feinberg School of Medicine
-
コンタクト：
- Jordan Wood, BS
- 電話番号：312-695-0915
- メール：jordan.wood1@northwestern.edu
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コンタクト：
- Bin Zhang, MS
- 電話番号：312-695-7771
- メール：bin.zhang1@northwestern.edu
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主任研究者：
- Charles Hogue, MD
-
副調査官：
- Ravindra A Gupta, MD
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副調査官：
- John Bebawy, MD
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副調査官：
- Eyal Kimchi, MD, PhD
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副調査官：
- Jacqueline Morano, MD
-
副調査官：
- Jamie Uejima, MD
-
副調査官：
- Kimberly Klafta, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia.
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Aim 3: Secondary Endpoint 1:EEG Monitoring Data
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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30 Days
|
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DRS-R-98
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Charles Hogue, MD、Northwestern University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月23日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2029年5月31日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月26日
最初の投稿 (実際)
2026年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月26日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STU00223307
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。