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

NCT07713368 | Not Yet Recruiting

• 1 other identifier: linyanshen[2026]205-002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection

Keywords

Transcranial Alternating Current Stimulation; Postoperative Anxiety; Intraspinal Tumor Resection; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Severity of postoperative anxiety

  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

  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

  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

  1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery

• Sleep quality assessed by Pittsburgh Sleep Quality Index score

  1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery

Other Outcomes (2)

• Serum substance P concentration

  2 days before surgery and 2 days after surgery

• Changes in Electroencephalographic Oscillations

  2 days before surgery and 2 days after surgery

Study Arms (2)

Active Transcranial Alternating Current Stimulation Group

EXPERIMENTAL

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

Sham Transcranial Alternating Current Stimulation Group

SHAM COMPARATOR

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)

Interventions

Transcranial Alternating Current Stimulation DEVICE

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.

Active Transcranial Alternating Current Stimulation Group

Sham (No Treatment) DEVICE

Wear the transcranial electrical stimulator without applying electric current

Sham Transcranial Alternating Current Stimulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, 100053, China

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

wei Xiao

CONTACT

+8613810971299; kitten15@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after publication
• Access Criteria: The study protocol can be obtained by contacting the PI after publication.

Locations

CN (1)