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

Xi Wu

Status: Begins enrollment in 2 months

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Treatments: Other: Sham acupuncture; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07357688

2025KL-111

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 research within a month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 3 patient groups

Verum acupuncture group (VA)

Experimental group

Description:

Acupoint with acupuncture treatment

Treatment:

Other: Acupuncture

Sham acupuncture group (SA)

Sham Comparator group

Description:

Non-acupoint with sham acupuncture treatment

Treatment:

Other: Sham acupuncture

Waitlist control group

No Intervention group

Description:

Acupoint with acupuncture treatment after 8-week waiting period