The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyeliti… (NCT07357688) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
China99 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 resear…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks