Quantitative Measurement of Brain State and Neurofeedback Intervention Techniques for the Treatment of Perioperative Neurocognitive Disorders in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 390
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The goal of this clinical trial is to learn if quantitative measurement of brain and neurofeedback intervention techniques works to prevent perioperative neurocognitive deficits in elderly oncology patients who are to undergo elective major surgery. The main questions it aims to answer are:
- Can neurofeedback intervention training reduce the incidence of postoperative delirium in elderly oncology patients? Researchers will compare the incidence of postoperative delirium in elderly oncology patients after training in neurofeedback intervention with those after living a normal life, to see if training in neurofeedback intervention before surgery is effective in preventing the development of postoperative delirium.
Participants will:
-
Take neurocognitive feedback intervention training for 14 days prior to surgery (recommended to be used for at least 1 hour per day for a cumulative preoperative use of 14 hours).
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Received preoperative and postoperative assessments of cognitive function by a third-party researcher, as well as daily delirium assessments for 7 days postoperatively.
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The subjects in the control group lived a normal life every day before the operation, and the rest of the measures were the same as those in the intervention group.
详细描述
- Study design: The present study is a randomized controlled clinical trial in which subjects were screened on the basis of inclusion and exclusion criteria and were randomised into the following control group (n=195) and intervention group (n=195) in a ratio of 1:1.
②Participants: A total of 390 patients will be enrolled in this study, all of whom will be elderly patients undergoing elective surgery at the Cancer Hospital of the Chinese Academy of Medical Sciences (CAMS)/Beijing Chaoyang Hospital (BCH)/Xuanwu Hospital (Xuanwu Hospital). The main inclusion and exclusion criteria are listed below: Inclusion criteria：
- Patients undergoing elective major surgery (colorectal, pancreatic-gastric, hepatobiliary, thoracic, gynaecological and urological) under general anaesthesia;
- Expected duration of surgery >2 hours;
- Age ≥65 years; Exclusion criteria：
- refused to participate in this study;
- preoperative MMSE score <26 or if the patient's educational level was lower than high school, MMSE <24 and active depressive state (GDS-15 score >9);
- underwent neurosurgery or the surgery itself interfered with the patient's postoperative communicative communication (e.g., tracheotomy);
- severe organ dysfunction;
- underwent cardiac surgery, (e) Undergoing cardiac surgery, neurosurgery, or neurosurgery; (f) ASA classification IV or higher.
③Sample size，Randomisation and blinding： Referring to the results of the previous study, assuming that the incidence of POD in patients in the intervention group was 8% and the incidence of POD in patients in the control group was 18%, according to the statistical efficacy of 80%, the test level of unilateral 0.025, and the test of superiority using the PASS 15 software Tests for Two Proportions, the calculation of the intervention group: the control group = 1:1, each of the two groups needed 177 cases. A total of 354 cases. Considering the dropout rate of about 10% during the clinical trial, the minimum number of cases in the intervention group and the control group was 195 cases, and it was estimated that a total of 390 cases were needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medical staff and outcome assessors were blinded to the fact that volunteers were responsible for obtaining the randomisation number, preparing the intervention equipment, and training in its use, and that patient follow-up, and assessment of relevant outcomes, were carried out by a trained investigator (anaesthetist), who was not involved in anaesthesia or perioperative management; medical staff and other investigators, except volunteers, were not aware of the subgroups; and the study was not blinded to the subjects.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective major surgery (colorectal, pancreatic-gastric, hepatobiliary, thoracic, gynaecological and urological) under general anaesthesia;
- •Expected duration of surgery >2 hours;
- •Age ≥65 years;
排除标准
- •refused to participate in this study;
- •preoperative MMSE score <26 or if the patient's educational level was lower than high school, MMSE <24 and active depressive state (GDS-15 score >9);
- •underwent neurosurgery or the surgery itself interfered with the patient's postoperative communicative communication (e.g., tracheotomy);
- •severe organ dysfunction;
- •underwent cardiac surgery, (e) Undergoing cardiac surgery, neurosurgery, or neurosurgery;
- •ASA classification IV or higher.
研究组 & 干预措施
Intervention Group
Subjects should undergo at least 2 consecutive weeks of uninterrupted closed-loop neurofeedback training prior to surgery. During the training cycle, subjects can train "Digital Meditation" (15-20 minutes) + "Idea Magic Ball" game (5-15 minutes) at least once a day in the morning and once in the afternoon, and then choose whether or not to play the "Chase Training" and "Concentration Training" games. The "Chase Training" and "Concentration Training" games should be played at your own choice. During the cycle, you need to perform "sleep induction" training once a night before going to bed (20-40 minutes), and complete the cumulative ≥14 hours of training (the length of time recorded by the APP) before the surgery. The total number of hours of training should be ≥14 before the surgery (APP records the number of hours of training).
干预措施: neurofeedback intervention training game (Combination Product)
Control Group
Control subjects lived a normal life before the operation.
结局指标
主要结局
Incidence of postoperative delirium
时间窗: 7 days after surgery
On postoperative days 1-7, the investigator assessed subjects for CAM daily from 8:00 am-12:00 pm and 14:00 pm-18:00 pm.
次要结局
- Number of occurrences of delirium(7 days after surgery)
- Severity of POD(7 days after surgery)
- Type of POD(7 days after surgery)