Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 568
- 试验地点
- 3
- 主要终点
- Incidence of delayed neurocognitive recovery
研究概览
简要总结
Patients with preoperative cognitive impairment are at increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Repetitive transcranial magnetic stimulation (rTMS) has been used to improve cognitive function in patients with cognitive impairement. This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.
详细描述
Mild cognitive impairment (MCI) affects 10-15% of the population over 65 years old. In patients for elective non-cardiac and emergency surgeries, the pooled prevalences of unrecognized cognitive impairment were 37.0% and 50.0%, respectively. Patients with preoperative cognitive impairment are at increased risk of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Therefore, perioperative neurocognitive protection is particularly important for patients with preoperative cognitive impairment.
Repetitive transcranial magnetic stimulation (rTMS) is a neural modulation technique. By acting on the brain and altering the membrane potential of cortical neurons, the generated pulsed magnetic fields affect neural metabolism and electrical activity and trigger a series of physiological and biochemical reactions. It was found that high frequency (>5 Hz) rTMS increases cortical excitability, whereas low frequency (<1Hz) rTMS reduces corticol excitability. The mechanism by which rTMS regulates brain function is generally believed to be related to the long-term enhancement and long-term inhibition of synaptic transmission function.
The left dorsolateral prefrontal cortex (DLPFC) is an important target of rTMS intervention for improving cognitive function. A meta-analysis showed that high-frequency rTMS on the DLPFC and low-frequency rTMS on the right medial prefrontal cortex improved memory function; high frequency rTMS on the right inferior frontal gyrus enhanced executive ability in non-surgical patients with mild cognitive impairment or Alzheimer's disease. Another meta-analysis showed that high-frequency rTMS on DLPFC is an effective therapeutic option for improving cognitive function in Alzheimer patients.
This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged ≥65 years;
- •Patients with preoperative mild to moderate cognitive impairment, defined as 9<Montreal Cognitive Assessment (MoCA)<26;
- •Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of >2 hours;
- •Expected to stay in hospital for at least 5 days after surgery.
排除标准
- •Left-handed;
- •Primary school education level or below;
- •Comorbid diseases including mental illness, intellectual disability, auditory and visual dysfunction, language impairment, severe neurological disorders, or other diseases that impede the completion of evaluation;
- •Neurosurgery;
- •Presence of contraindications to rTMS treatment, including epilepsy, pregnant or lactating women, or with a metal or electric implanted device (e.g., deep brain stimulator, ventriculoperitoneal shunt, aneurysm clip, pacemaker, cochlear implant, or surgical staples on the scalp);
- •Other situations that are deemed unsuitable for inclusion in the study.
结局指标
主要结局
Incidence of delayed neurocognitive recovery
时间窗: On the 5th day after surgery
Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher score indicating better function) before surgery and at 5 days after surgery. A MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of delayed neurocognitive recovery.
次要结局
- Incidence of delirium(Within 5 days after surgery)
- Incidence of postoperative neurocognitive disorder at 30 days after surgery(On the 30(±3)th day after surgery)
- Incidence of postoperative neurocognitive disorder at 180 days after surgery(On the 180(±15)th day after surgery)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital