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Myalgic Encephalomyelitis/Chronic Fatigue SyndromeNCT07357688

The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

A study testing Acupuncture in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by Xi Wu at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
2 sitesChina
Study dates
May 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites
  • Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 611130

    Xi Wu, +86-18008020710, wuxi@cdutcm.edu.cn

  • Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 611130

Other trials in China

About this study

Official title: The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Study With Multimodal Magnetic Resonance Imaging

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.

Read more

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.

Being tested
Acupuncture, Sham acupuncture
Keywords
Post-COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome, hippocampus, cognitive function, neurochemical, functional connectivity, multimodal MRI, acupuncture
Medical subject headings
Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureOther

    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.

  • Sham acupunctureOther

    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.

Study groups in NCT07357688
Study groupRoleWhat they receive
Verum acupuncture group (VA)ExperimentalAcupoint with acupuncture treatment
Receives: Other: Acupuncture
Sham acupuncture group (SA)Sham comparatorNon-acupoint with sham acupuncture treatment
Receives: Other: Sham acupuncture
Waitlist control groupNo interventionAcupoint with acupuncture treatment after 8-week waiting period

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 8 weeks

Secondary outcomes (21)
  1. Changes of Digit Span Test scores from baseline to the end of 8 weeks

    Digit Span Test consists of forward and backward subtests, that respectively assess attention and executive function through measuring the number of correct digit sequences. The minimum score is 0 , and the maximum scores are respectively 10 and 9 for forward and backward subtests. Higher scores indicate better attention and executive function.

    Measured: Baseline and 8 weeks

  2. Changes of Trail Making Test scores from baseline to the end of 8 weeks

    Trail Making Test includes Part A(TMT-A) and Part B(TMT-B), that respectively evaluates attention and executive function via measuring the time in seconds required for completion of each part of the test. Higher scores indicate worse attention and executive function.

    Measured: Baseline and 8 weeks

  3. Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks

    Rey Auditory Verbal Learning Test evaluates different aspects of verbal memory through measuring total learning, repetitions, delayed recall, retroactive interference, and proactive interference. Higher scores for total learning and delayed recall indicate better memory, while higher scores for repetitions, retroactive interference, and proactive interference indicate worse memory.

    Measured: Baseline and 8 weeks

  4. Changes of Stroop Test scores from baseline to the end of 8 weeks

    Stroop test consists of Stroop word test(Part A), Stroop color test(Part B) and Stroop color word test(Part C), that assess executive function through measuring the time in second required to complete each part and the number of errors for each part. Higher score for each part indicates worse executive function.

    Measured: Baseline and 8 weeks

  5. Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks

    Rey-Osterrieth Complex Figure Test evaluates visuospatial construction ability through measuring the accuracy of copy, and evaluates visual memory via measuring the accuracies of immediate and delayed recalls. Higher scores indicate better visuospatial construction and visual memory.

    Measured: Baseline and 8 weeks

  6. Change of Verbal Fluency Test Scores from baseline to the end of 8 weeks.

    Verbal Fluency Test includes Phonemic Fluency Test, Category Fluency Test and Action Fluency Test, that evaluate language. Verbal Fluency Test measures the number of correct words produced under restricted search conditions of phonemic(letter F), category(animals) and action(kitchen actions). Higher score for each subtest indicates better language.

    Measured: Baseline and 8 weeks

  7. Change of Boston Naming Test from baseline to the end of 8 weeks

    Boston Naming Test includes 30 items and evaluates language through measuring the total of correct responses. The minimum score is 0, and the maximum score is 30. Higher score indicates better language.

    Measured: Baseline and 8 weeks

  8. Change of Multidimensional Fatigue Inventory score from baseline to the end of 8 weeks

    Multidimensional Fatigue Inventory is a self-report instrument consisting of 20-item devised to evaluate fatigue through measuring the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. The minimum score is 20 ,and the maximum score is 100. Higher score indicate greater severity of fatigue.

    Measured: Baseline and 8 weeks

  9. Change of Pittsburgh Sleep Quality Index from baseline to the end of 8 weeks

    Pittsburgh Sleep Quality Index is a self-report questionnaire with 19 items, that assesses general sleep quality within 1 month through measuring the components of Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. The total score ranges from 0 to 21. Higher score indicates worse sleep quality.

    Measured: Baseline and 8 weeks

  10. Change of the Generalized Anxiety Disorde-7 score from baseline to the end of 8 weeks

    Generalized Anxiety Disorde-7 is a self-report questionnaire with 7 items, that assesses the level of anxiety in the past two week. The minimum score is 0, and the maximum score is 21. Higher score indicates greater severity of anxiety.

    Measured: Baseline and 8 weeks

  11. Change of Hamilton Depression Scale from baseline to the end of 8 weeks

    Hamilton Depression Scale is the most commonly used instrument for the assessment of depression in clinical practice. It includes 24 items and assesses the level of depression through measuring factors of Anxiety/Somatization, Weight, Cognitive Impairment, Diurnal Variation, Retardation, Sleep Disturbance, and Hopelessness. The total score range is 0 to 76. Higher total score indicates greater level of depression.

    Measured: Baseline and 8 weeks

  12. Change of the MOS Item Short From Health Survey from baseline to the end of 8 weeks

    The MOS Item Short From Health Survey is a self-report instrument with 36 items, that assesses quality of life through measuring subscales of Physical Function, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher subscores indicate better quality of life.

    Measured: Baseline and 8 weeks

  13. The change in level of N-acetylaspartate(NAA)at each hippocampus from baseline to the end of 8 weeks.

    The level of NAA will be represented as the NAA to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS).

    Measured: Baseline and 8 weeks.

  14. The change in level of choline(Cho)at each hippocampus from baseline to the end of 8 weeks.

    The level of Cho will be represented as the Cho to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  15. The change in level of glutamate (Glu) at each hippocampus from baseline to the end of 8 weeks.

    The level of Glu will be represented as the Glu to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  16. The change in level of glutamine (Gln) at each hippocampus from baseline to the end of 8 weeks.

    The level of Gln will be represented as the Gln to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  17. The change in level of lactate (Lac) at each hippocampus from baseline to the end of 8 weeks.

    The level of Lac will be represented as the Lac to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  18. The change in level of myo-inositol (mI) at each hippocampus from baseline to the end of 8 weeks.

    The level of mI will be represented as the mI to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  19. The change in level of glycerophosphorylcholine (GPC) at each hippocampus from baseline to the end of 8 weeks.

    The level of GPC will be represented as the GPC to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  20. The change in level of glutathione (GSH) at each hippocampus from baseline to the end of 8 weeks.

    The level of GSH will be represented as the GSH to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)

    Measured: Baseline and 8 weeks

  21. The change of resting-state functional connectivity(RSFC) at each hippocampus from baseline to the end of 8 weeks.

    The RSFC for each hippocampus will be examined with functional Magnetic Resonance Imaging(fMRI).

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357688
Sponsor's protocol ID
2025KL-111
Status last verified
Jan 2026
First submitted
1 Jan 2026
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: There is not a plan to make individual participant data (IPD) available to other researchers at this time.

Publications

  • Luo T, Luo Y, Huang L, Jin H, An Y, Huang J, Luo K, Guo Y, Wang D, Liu D, Wu X. Exploring the mechanisms of acupuncture in improving cognitive function in post-COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome: study protocol for a randomized controlled trial using multimodal MRI. Front Neurol. 2026 Jun 3;17:1793397. doi: 10.3389/fneur.2026.1793397. eCollection 2026.

    PubMed 42383026

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by Xi Wu at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tingting Luo (+86-18782007605, 1970001905@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357688, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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