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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
• Intervention / Treatment: Device: Transcranial Alternating Current Stimulation; Device: Sham (No Treatment)

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wei Xiao; Phone Number: +8613810971299; Email: kitten15@126.com

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital
    • Contact: Wei Xiao, Doctor; Phone Number: 8613810971299; Email: kitten15@126.com
    • Principal Investigator: Wei Xiao, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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 Comparator: 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.	Device: Sham (No Treatment); Wear the transcranial electrical stimulator without applying electric current

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Anxiety Within 3 Days After Surgery	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative anxiety	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	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	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	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	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	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	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	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	Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.	Up to 30 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum substance P concentration	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	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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Alternating Current Stimulation; Postoperative Recovery; Postoperative Anxiety; Intraspinal Tumor Resection
• Additional Relevant MeSH Terms: Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: linyanshen[2026]205-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol can be obtained by contacting the PI after publication.
• IPD Sharing Time Frame: 1 year after publication
• IPD Sharing Access Criteria: The study protocol can be obtained by contacting the PI after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No