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Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection

15. Juli 2026 aktualisiert von: Xuanwu Hospital, Beijing

The incidence of postoperative anxiety in surgery ranges from 4.1% to 79.6% , and among patients undergoing intraspinal tumor resection surgery, the incidence of postoperative anxiety is as high as 46.7%.Adverse effects induced by anxiety include insomnia, exacerbated pain, impaired wound healing and immune function, increased risk of adverse cardiovascular events, and postoperative cognitive dysfunction. These may lead to postoperative depression and chronic pain, significantly delaying patient recovery.

The goal of this study is to investigate the effects of intraoperative transcranial alternating current stimulation on postoperative anxiety in adult patients undergoing intraspinal tumor resection. It will also evaluate the safety of the transcranial alternating current stimulation.

This study will enroll adult patients undergoing elective intraspinal tumor resection surgery. The study will compare the transcranial alternating current stimulation with a sham stimulation to see whether the intervention can reduce the incidence of postoperative anxiety. The trial will also compare the anxiety scores, the incidence of delirium, pain scores, frial scores, sleep quality scores, recovery quality scores and adverse events between intervention and control groups. We also plan to compare the electroencephalography parameters and serum level of substance P to investigate the potential mechanism.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

102

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

  • China
      • Beijing, China, 100053
        • Xuanwu Hospital
        • Kontakt:
        • Hauptermittler:
          • Wei Xiao, Doctor

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:

  • Age 18 to 65 years old
  • Scheduled for elective intraspinal tumor resection under general anesthesia
  • American Society of Anesthesiologists physical status I-III
  • Able to understand and complete the Hospital Anxiety and Depression Scale and other study-related questionnaires
  • Voluntarily sign the informed consent form
  • Right handed

Exclusion Criteria:

  • Preoperative HADS-A score ≥ 8
  • History of psychiatric disorders (e.g., depression, psychosis) or use of psychotropic medications within the past 3 months
  • History of neurological diseases (e.g., epilepsy, stroke, dementia) or severe head trauma
  • Contraindications to transcranial alternating current stimulation, including metallic implants in the head, skull defects, or a history of seizures
  • Severe visual or auditory impairment that affects communication
  • severe cardiovascular and cerebral vascular diseases
  • Participation in other clinical trials within the past 30 days
  • A Mini-Mental State Examination (MMSE) score < 15

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Active Transcranial Alternating Current Stimulation Group
Participants receive active transcranial alternating current stimulation (tACS) at 10 Hz, 2 mA, applied bilaterally over the prefrontal cortex (F3/F4) for 20 minutes immediately after anesthesia induction during intraspinal tumor resection. All participants receive standard anesthesia and surgical care per institutional protocols.
Gerät: Transcranial Alternating Current Stimulation
This study uses intraoperative transcranial alternating current stimulation (tACS) delivered via a non-invasive, portable electrical stimulation device. The intervention consists of 10 Hz alternating current at 2 mA intensity, applied bilaterally over the prefrontal cortex (F3/F4 electrode positions) for 20 minutes immediately following anesthesia induction during elective intraspinal tumor resection. The device is calibrated to deliver a consistent, low-level current that does not interfere with standard anesthesia or surgical procedures.
Schein-Komparator: Sham Transcranial Alternating Current Stimulation Group
Participants receive sham transcranial electrical stimulation without electric current during the perioperative period. All participants receive standard anesthesia and surgical care per institutional protocols, identical to the tACS group except for the study-specific stimulation intervention.
Gerät: Sham (No Treatment)
Wear the transcranial electrical stimulator without applying electric current

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Postoperative Anxiety Within 3 Days After Surgery
Zeitfenster: From the day of surgery up to postoperative day 3
The primary outcome is the incidence of postoperative anxiety, defined as a Hospital Anxiety and Depression Scale-Anxiety score ≥ 8 at any time point on the day of surgery or postoperative days 1, 2, or 3. Participants will be assessed by trained evaluators blinded to group allocation.
From the day of surgery up to postoperative day 3

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Severity of postoperative anxiety
Zeitfenster: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
Anxiety severity will be evaluated using the Hospital Anxiety and Depression Scale-Anxiety score. Assessments will be performed at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery.
1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score
Zeitfenster: In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
Postoperative delirium will be evaluated using the 3-minute Diagnostic Confusion Assessment Method score. Assessments will be performed in the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3.
In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
Postoperative pain intensity assessed by Numeric Rating Scale score
Zeitfenster: 1 day before surgery, 6, 24, 48, and 72 hours after surgery
Postoperative pain intensity will be evaluated using the Numeric Rating Scale score at 1 day before surgery and at 6, 24, 48, and 72 hours after surgery.
1 day before surgery, 6, 24, 48, and 72 hours after surgery
Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score
Zeitfenster: 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
Frailty will be evaluated using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score at 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery.
1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
Sleep quality assessed by Pittsburgh Sleep Quality Index score
Zeitfenster: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index score at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery.
1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
Quality of recovery assessed by 15-item Quality of Recovery score
Zeitfenster: Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery score on the day of surgery, postoperative days 1, 2, 3, and 1 month after surgery.
Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
Time to ambulation
Zeitfenster: Day of surgery, postoperative days 1, 2, 3
Time to first ambulation after surgery will be recorded and compared between groups.
Day of surgery, postoperative days 1, 2, 3
Length of hospital stay
Zeitfenster: From the day when patient hospitalization to 3 weeks after surgery
Total length of hospital stay will be recorded and compared between groups.
From the day when patient hospitalization to 3 weeks after surgery
Incidence of adverse events, complications, and 30-day all-cause mortality
Zeitfenster: Up to 30 days after surgery
Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.
Up to 30 days after surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serum substance P concentration
Zeitfenster: 2 days before surgery and 2 days after surgery
Serum substance P levels will be measured by enzyme-linked immunosorbent assay (ELISA) at baseline (2 days before surgery), and at 2 days after surgery.
2 days before surgery and 2 days after surgery
Changes in Electroencephalographic Oscillations
Zeitfenster: 2 days before surgery and 2 days after surgery
Resting-state electroencephalography will be recorded at baseline (2 days before surgery), and at 2 days after surgery. Changes in power spectral density (delta, theta, alpha, beta bands) and functional connectivity will be analyzed. The association between these changes and postoperative anxiety outcomes will be explored.
2 days before surgery and 2 days after surgery

Mitarbeiter und Ermittler

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

Sponsor

Xuanwu Hospital, Beijing

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 (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. März 2029

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2026

Zuerst gepostet (Tatsächlich)

20. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • linyanshen[2026]205-002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The study protocol can be obtained by contacting the PI after publication.

IPD-Sharing-Zeitrahmen

1 year after publication

IPD-Sharing-Zugriffskriterien

The study protocol can be obtained by contacting the PI after publication.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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