The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Study With Multimodal Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
研究概览
简要总结
Background of study:
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a common sequela after SARS-CoV-2 infection(COVID-19). Cognitive dysfunction is one of the most common debilitating symptoms in ME/CFS. Currently, standardized therapy for ME/CFS has not been established. Some treatments, such as cognitive behavioral therapy (CBT) and graded exercise therapy (GET), mainly exert effects on physical symptoms, whereas the influence on cognitive problems is not significant. Acupuncture is an important complementary and alternative therapy for ME/CFS. However, However, research focused on the impact of acupuncture on cognitive functions in ME/CFS is rare. Additionally, no study has evaluated the efficacy and mechanism of acupuncture treatment in improving cognitive functions for post-COVID-19 ME/CFS.
Objective of the study:
The first objective of this study is to assess the efficacy of acupuncture treatment in improving cognitive function for post-COVID-19 ME/CFS. The second objective is to explore whether acupuncture improves cognitive ability in patients with post-COVID-19 ME/CFS through modulating hippocampal connectivity and metabolites using multimodal magnetic resonance imaging(MRI).
Study design:
A prospective, three-armed, randomized controlled trial with resting-state functional MRI(rs-fMRI) and magnetic resonance spectroscopy(MRS). Adults with post-COVID-19 ME/CFS 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 functions and resting-state functional connectivity(RSFC) and the levels of metabolites for each hippocampus will be examined at baseline and 8th week.
Study population:
Patients fulfilling 2015 National Academy of Medicine (NAM) criteria for ME/CFS following COVID-19.
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
- •18-60 years old
- •Fatigue occurred during or after initial recovery of COVID-19 confirmed by nasopharyngeal swab reverse transcription-polymerase chain reaction(RT-PCR) or antigen testing lasts for at least 6 months
- •Fulfilling US National Academy of Medicine(NAM) criteria for ME/CFS
- •Chinese native speaker
- •Right handedness
- •Voluntary to participate in the study and signing the informed consent form.
排除标准
- •Persistent fatigue occurs prior to COVID-19
- •Previous or current diagnosis of severe chronic diseases such as heart, kidney or liver failure, tumor
- •Previous or current diagnosis of neurological or psychiatric disorder such as neurodegenerative disease, stroke, epilepsy, bipolar disorder, schizophrenia
- •Previous or current diagnosis of endocrine or metabolic disease such as hypothyroidism, adrenocortical hypofunction, type 2 diabetes
- •Previous or current diagnosis of autoimmune disease such as systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis
- •Chronic infection or inflammatory disease such as acquired immune deficiency syndrome(AIDS), chronic hepatitis, irritable bowel syndrome
- •Substance or alcohol abuse
- •Obesity (Body Mass Index≥28)
- •Long-term use of immunosuppressant or glucocorticoid
- •Within one year after major surgery
- •Metal or electronic device implants
- •Claustrophobia
- •Pregnancy or lactation
- •Previous acupuncture treatment in the latest 3 months
- •Participating in another clinical research within a month
研究者
Xi Wu
Professor
Chengdu University of Traditional Chinese Medicine