EEG-TMS Intervening Against Postoperative Delirium in Elderly Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Duration of postoperative delirium
研究概览
简要总结
Postoperative delirium is common in elderly surgical patients and is associated with complications and prolonged hospitalisation. The aim of the RECOVER study is to assess the efficacy of electroencephalo graph (EEG)-transcranial magnetic stimulation (TMS) treatment for the management of postoperative delirium.
详细描述
Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS), a pattern of TMS, was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network.This project team conducted a pilot study in the early stage and innovatively applied cTBS to treat postoperative delirium in elderly patients. The results preliminarily elucidate the safety, and feasibility of TMS in treating postoperative delirium in elderly patients.
In order to confirm the effectiveness of EEG-TMS therapy for POD and observe its impact on long-term prognosis, this project will conduct a prospective randomized controlled study to compare TMS therapy with sham stimulation therapy. The study will observe The duration of postoperative delirium during the 7-day intervention period, as well as severity of delirium, the time to successful discharge (defined as the patient surviving outside the hospital for at least 48 hours after discharge), and the 30-day and 90-day survival times, the number of patients receiving salvage drug treatment, and the number of days each patient received salvage drug treatment, the sensitivity, specificity, and predictive value of EEG. The trial will provide new ideas for the prediction and treatment of postoperative delirium in clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The effective coil or false coil shapes of the TMS group and the SHAM group were consistent. The assigned coils will blind clinical staff, patients, researchers, and outcome assessors who treat patients, and only data management personnel may unblind the assigned intervention measures. The statistical analysis of this experiment will be conducted using blinding, with the intervention group coded as (e.g. X and Y). Based on this blind analysis, two conclusions will be drawn: assuming X is the experimental group and Y is the control group, the other conclusion assumes the opposite. Two abstracts will be written and accepted by the author team. Afterwards, the blindness will be lifted.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years;
- •Scheduled for non-cardiac surgery;
- •Positive assessment for delirium via the CAM-ICU or 3D-CAM after surgery.
排除标准
- •Chronic use of antipsychotic medications;
- •Receipt of antipsychotic drugs prior to enrollment;
- •Permanently incapacitated patients (lacking decision-making capacity);
- •Inability to undergo delirium assessment (e.g., due to language barriers, deafness, blindness, aphasia, or coma);
- •Treatment withdrawal or brain death;
- •Known pregnancy or lactation;
- •Inability to obtain informed consent per national regulations;
- •Patients under compulsory hospitalization (involuntary commitment) by regulatory authorities;
- •Alcohol withdrawal delirium (delirium tremens);
- •Contraindications to transcranial magnetic stimulation (TMS);
- •Acute infectious diseases.
研究组 & 干预措施
TMS group
The TMS group uses effective coils for transcranial magnetic stimulation treatment twice a day, with a treatment mode of continuous theta burst stimulation (cTBS). The stimulation intensity is set at 80% of the minimum exercise threshold.
干预措施: continuous Theta-burst stimulation (Device)
SHAM group
For patients who experience postoperative delirium and are randomly assigned to the sham group, false coil stimulation is used. The auditory and scalp sensations induced by false coil stimulation are similar to those induced by effective coil stimulation, but there is no electromagnetic penetration into the brain or neural activation.
干预措施: Sham (Device)
结局指标
主要结局
Duration of postoperative delirium
时间窗: 7 days
Trained clinicians (who have received standardized CAM-ICU/3D-CAM training) will assess patients for POD using either the CAM-ICU or 3D-CAM tool twice a day.
次要结局
- Survival at 30 and 90 days(90 days)
- Severity of delirium(7 days)
- Time to successful hospital discharge(90 days)
- Number of patients receiving rescue medications(7 days)
- Total days of rescue medication use per patient(7 days)