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

Обзор

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.

Вмешательства

• Устройство 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 wit
• Устройство Sham (No Treatment)
  Wear the transcranial electrical stimulator without applying electric current

Первичные конечные точки

• Incidence of Postoperative Anxiety Within 3 Days After Surgery [Срок оценки: From the day of surgery up to postoperative day 3]

Вторичные конечные точки (9)

• Severity of postoperative anxiety [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery]
• Sleep quality assessed by Pittsburgh Sleep Quality Index score [Срок оценки: 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 [Срок оценки: Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery]
• Time to ambulation [Срок оценки: Day of surgery, postoperative days 1, 2, 3]
• Length of hospital stay [Срок оценки: From the day when patient hospitalization to 3 weeks after surgery]
• Incidence of adverse events, complications, and 30-day all-cause mortality [Срок оценки: Up to 30 days after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Xuanwu Hospital — Пекин

Идентификаторы

NCT: NCT07713368 · linyanshen[2026]205-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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