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

15. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

102

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina, 100053
        • Xuanwu Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Wei Xiao, Doctor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Sham-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.
Enhed: Sham (No Treatment)
Wear the transcranial electrical stimulator without applying electric current

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Anxiety Within 3 Days After Surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of postoperative anxiety
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum substance P concentration
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xuanwu Hospital, Beijing

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. marts 2029

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • linyanshen[2026]205-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

1 year after publication

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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