The Effect of Acupuncture Treatment on Cognitive Functions and Brain Networks for Long COVID: a Multimodal Magnetic Resonance Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
研究概览
简要总结
Background of study:
Long COVID(LC) is a prevalent sequalae of SARS-CoV-2 infection and can affect multiple organ systems. Cognitive dysfunction is one of the most common symptoms in LC with 22% prevalence. It can persist for years and significantly reduce patients' quality of life. Brain network is the neural basis underlying human cognitive processes. Diffusion tensor imaging (DTI) and functional magnetic resonance imaging(fMRI) research has revealed that alterations of network characteristics were associated with cognitive impairments across attention, memory, executive function and language in LC. Currently, there is no accepted therapy for cognitive impairment in LC. Acupuncture, as a Traditional Chinese Medicine therapy, has potential to improve cognitive deficits for LC. However, research focusing on the impact of acupuncture on cognitive functions in LC is rare. Additionally, no one has evaluated the mechanism of acupuncture improving cognitive functions in LC.
Objective of the study:
This study aims to assess the effect of acupuncture treatment on cognitive function and explore the central mechanism of acupuncture therapy in improving cognitive function for LC using cognitive assessments, DTI and resting-state fMRI.
Study design:
A prospective, three-armed, randomized controlled trial with DTI and rs-fMRI. Adults with LC will be randomly assigned to acupuncture, sham acupuncture, or waitlist control group in a 1:1:1 ratio, receiving 8-week intervention or waiting. Cognitive function and topological attributes of brain networks will be examined at baseline and 8th week.
Study population:
Patients fulfilling World Health Organization (WHO) criteria for LC will be included in this study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
data analysts
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years
- •Fulfilling WHO criteria for long COVID
- •History of confirmed COVID-19 through RT-PCR of nasopharyngeal swab or antigen test of nasal swab ;
- •Having subjective cognitive problems
- •Native Chinese speakers
- •Right handedness
- •Voluntary to participate in the study and signing the informed consent form.
排除标准
- •Preexisting cognitive symptoms before COVID-19
- •Previous or current diagnosis of chronic conditions that may affect cognitive performances (such as neurological, psychiatric disorders, organ failure, chronic infectious diseases)
- •Prior loss of consciousness
- •History of major surgery within a year
- •Long-term use of drugs that may influence cognition(such as tranquilizer, antidepressant, immunosuppressor)
- •Previous acupuncture treatment within 3 months
- •Involvement of other clinical study within 4 weeks
- •Obesity(BMI≥28)
- •Sensory disorders(deafness, color blindness)
- •Limb dysfunction
- •Metal implantation
- •Claustrophobia
- •Pregnancy or lactation
研究者
Tingting Luo
Doctor
Chengdu University of Traditional Chinese Medicine