The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
1 other identifier
interventional
99
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 22, 2026
January 1, 2026
1.6 years
January 1, 2026
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks
Symbol Digit Modality Test assesses attention through measuring the number of correct responses within 90 seconds. The minimum score is 0, and the maximum score is 110. Higher score indicates better attention.
Baseline and 8 weeks
Secondary Outcomes (21)
Changes of Digit Span Test scores from baseline to the end of 8 weeks
Baseline and 8 weeks
Changes of Trail Making Test scores from baseline to the end of 8 weeks
Baseline and 8 weeks
Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks
Baseline and 8 weeks
Changes of Stroop Test scores from baseline to the end of 8 weeks
Baseline and 8 weeks
Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks
Baseline and 8 weeks
- +16 more secondary outcomes
Other Outcomes (1)
The number of participants with treatment-related adverse events recorded in Case Report Form(CRF) at the end of treatment at 8 weeks
8 weeks
Study Arms (3)
Verum acupuncture group (VA)
EXPERIMENTALAcupoint with acupuncture treatment
Sham acupuncture group (SA)
SHAM COMPARATORNon-acupoint with sham acupuncture treatment
Waitlist control group
NO INTERVENTIONAcupoint with acupuncture treatment after 8-week waiting period
Interventions
Participants will be alternatively acupunctured on two set of acupoints . The first set of acupuncture points incudes Baihui (GV20), bilateral Shenmen (HT7), bilateral Neiguan (PC6), Qihai (CV6), Guanyuan (CV4), bilateral Zusanli (ST36), bilateral Sanyinjiao (SP6). The second set of acupoints consist of Sishenchong (EX-HN1), bilateral Ganshu (BL18), bilateral Pishu (BL20), bilateral Shenshu (BL23), bilateral Taixi (KI3).The treatment consists of 24 sessions of 30 minutes, given within eight weeks (three sessions per week). A set of acupoints is acupunctured each treatment session.
Nonpenetrating acupuncture on non-acupoints will be performed using Park sham acupuncture device (0.25 mm in diameter and 40 mm in length, Hwatuo, Suzhou, China) for participants. Two sets of non-acupoints will be alternatively acupunctured. The first set of sham acupoints includes bilateral non-acupoint 1, bilateral non-acupoint 2, non-acupoint 3, non-acupoint 4, bilateral non-acupoint 5, bilateral non-acupoint 6. The second set consists of bilateral non-acupoint 7, bilateral non-acupoint 8, bilateral non-acupoint 9, bilateral non-acupoint 10. The treatment consists of 24 sessions of 30 minutes, given within eight weeks (three sessions per week). A set of non-acupoints will be acupunctured each treatment session.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xi Wulead
Study Sites (2)
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 611130, China
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 611130, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- data analysts
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 1, 2026
First Posted
January 22, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 22, 2026
Record last verified: 2026-01