Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
2026年7月15日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
102
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：wei Xiao
- 電話番号：+8613810971299
- メール：kitten15@126.com
研究場所
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Beijing、中国、100053
- Xuanwu Hospital
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コンタクト：
- Wei Xiao, Doctor
- 電話番号：8613810971299
- メール：kitten15@126.com
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主任研究者：
- Wei Xiao, Doctor
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Postoperative Anxiety Within 3 Days After Surgery
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Severity of postoperative anxiety
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serum substance P concentration
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2029年3月31日
試験登録日
最初に提出
2026年7月13日
QC基準を満たした最初の提出物
2026年7月15日
最初の投稿 (実際)
2026年7月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- linyanshen[2026]205-002
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The study protocol can be obtained by contacting the PI after publication.
IPD 共有時間枠
1 year after publication
IPD 共有アクセス基準
The study protocol can be obtained by contacting the PI after publication.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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