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临床试验/NCT05239897
NCT05239897已完成不适用

Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Cure rate of POD after a single cTBS treatment

研究概览

简要总结

To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.

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) 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. Therefore, we plan to conduct an exploratory study in participants undergoing elective surgeries to determine whether cTBS can cure POD in this senior patient population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 60 to 80 years;
  • Having delirium after elective surgery;
  • Being able to complete cognitive assessment and confusion assessment methods (CAM);
  • Willing to participate before surgery and being competent to provide informed consent.

排除标准

  • Having brain tumor, stroke, or mental disorders (e.g., depression or dementia);
  • Having contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head or heart);
  • Participating in other clinical studies.

结局指标

主要结局

Cure rate of POD after a single cTBS treatment

时间窗: 7 days after surgery

No POD was evaluated by CAM at 1 hour after a single cTBS treatment on the day of the first occurrence of POD and at any time point thereafter.

次要结局

  • Cure rate of POD after multiple cTBS treatments(7 days after surgery)
  • Severity of postoperative delirium changed after each cTBS treatment(7 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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