Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
2026년 7월 15일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
102
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: wei Xiao
- 전화번호: +8613810971299
- 이메일: kitten15@126.com
연구 장소
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Beijing, 중국, 100053
- Xuanwu Hospital
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연락하다:
- Wei Xiao, Doctor
- 전화번호: 8613810971299
- 이메일: kitten15@126.com
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수석 연구원:
- Wei Xiao, Doctor
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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가짜 비교기: 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.
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Wear the transcranial electrical stimulator without applying electric current
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Postoperative Anxiety Within 3 Days After Surgery
기간: From the day of surgery up to postoperative day 3
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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.
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From the day of surgery up to postoperative day 3
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Severity of postoperative anxiety
기간: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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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.
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1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score
기간: In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
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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.
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In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
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Postoperative pain intensity assessed by Numeric Rating Scale score
기간: 1 day before surgery, 6, 24, 48, and 72 hours after surgery
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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.
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1 day before surgery, 6, 24, 48, and 72 hours after surgery
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Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score
기간: 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
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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.
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1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Sleep quality assessed by Pittsburgh Sleep Quality Index score
기간: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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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.
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1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Quality of recovery assessed by 15-item Quality of Recovery score
기간: Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
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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.
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Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
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Time to ambulation
기간: Day of surgery, postoperative days 1, 2, 3
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Time to first ambulation after surgery will be recorded and compared between groups.
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Day of surgery, postoperative days 1, 2, 3
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Length of hospital stay
기간: From the day when patient hospitalization to 3 weeks after surgery
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Total length of hospital stay will be recorded and compared between groups.
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From the day when patient hospitalization to 3 weeks after surgery
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Incidence of adverse events, complications, and 30-day all-cause mortality
기간: Up to 30 days after surgery
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Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.
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Up to 30 days after surgery
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Serum substance P concentration
기간: 2 days before surgery and 2 days after surgery
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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.
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2 days before surgery and 2 days after surgery
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Changes in Electroencephalographic Oscillations
기간: 2 days before surgery and 2 days after surgery
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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.
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2 days before surgery and 2 days after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2028년 12월 31일
연구 완료 (추정된)
2029년 3월 31일
연구 등록 날짜
최초 제출
2026년 7월 13일
QC 기준을 충족하는 최초 제출
2026년 7월 15일
처음 게시됨 (실제)
2026년 7월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 15일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- linyanshen[2026]205-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The study protocol can be obtained by contacting the PI after publication.
IPD 공유 기간
1 year after publication
IPD 공유 액세스 기준
The study protocol can be obtained by contacting the PI after publication.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .