Impact of Perioperative Transcranial Photobiomodulation on Delayed Neurocognitive Recovery in Older Patients After Surgery: a Randomized, Double-blind, Pseudo-modulation-controlled Preliminary Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of delayed neurocognitive recovery
研究概览
简要总结
Delayed neurocognitive recovery is a common neurocognitive complication in older patients after surgery, especially those with preoperative neurocognitive decline. Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. This technique has been used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce the incidence of delayed neurocognitive recovery in older patients with pre-existing neurocognitive impairment.
详细描述
Along with the aging population, the number of older adults undergoing surgery is increasing. Neurocognitive complications (such as delirium and delayed neurocognitive recovery) are common in older patients after surgery, especially those with pre-existing neurocognitive decline. Occurrence of neurocognitive complications are associated with wose early and long-term outcomes.
Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. Study results in healthy volunteers showed favorable effects on neurocognitive functions. This technique has been safely used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. Transcranial photobiomodulation therapy may reduce postopeative neurocognitive complications in high risk patients but evience is limited.
This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce neurocognitive complications in older patients with pre-existing neurocognitive impairment. The primary endpoint is delayed neurocognitive recovery; secondary endpoints include postoperative delirium.
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, Care Provider, 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
- 是
入选标准
- •Aged 65 years or older.
- •Preoperative Mini-Mental State Examination (MMSE) <
- •Scheduled to undergo non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration >1 hour.
- •Planned hospital stay of at least 1 day before surgery and at least 2 days after surgery.
排除标准
- •Communication barriers before surgery due to coma, severe dementia, or language disorders.
- •History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or delirium before surgery.
- •History of brain injury, tumors, or surgery, or intracranial metal implants, or skin or soft tissue injuries on the head or face.
- •History of ischemic or hemorrhagic stroke within 3 months before surgery.
- •An American Society of Anesthesiologists class ≥ IV.
- •Enrolled in other interventional studies.
- •Other conditions deemed unsuitable for study participation.
研究组 & 干预措施
Intervention Group
A transcranial photobiomodulation therapy device employing medium-intensity LED near-infrared light will be applied to the forehead of participants. Treatments will be done twice daily on the day before surgery and on the first and second days after surgery, and once on the day of surgery, with at least 8 hours between any two interventions.
干预措施: Transcranial photobiomodulation therapy (Device)
Controll Group
A transcranial photobiomodulation therapy device employing extremely low-intensity LED near-infrared light will be applied to the forehead of participants. Treatments will be done twice daily on the day before surgery and on the first and second days after surgery, and once on the day of surgery, with at least 8 hours between any two interventions.
干预措施: Transcranial pseudo-photobiomodulation (Device)
结局指标
主要结局
Incidence of delayed neurocognitive recovery
时间窗: On the 4th day after surgery or before discharge if earlier
Cognitive function will be assessed at baseline and at 4 days after surgery (or before hospital discharge if ealier) using the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitive function). Delayed neurocognitive decline (dNCR) is defined as: a \|Z\| value of decline in MoCA score ≥1.96. Z value = \[(change from baseline in MoCA score in a surgical patient - mean change from baseline in MoCA score in the non-surgical group)\] / (standard deviation of change from baseline in MoCA score in the non-surgical group).
次要结局
- Incidence of postoperative delirium(Up to 3 days after surgery)
- Incidence of postoperative neurocognitive disorder(At 30 days after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Peking University First Hospital