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

ConditionMyalgic Encephalomyelitis/Chronic Fatigue Syndrome

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorXi Wu

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Acupuncture
Other intervention
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 acupuncture
Other intervention
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.

Treatment groups

99 Participants

are divided into 3 treatment groups

Group A: Verum acupuncture group (VA)Experimental treatment 1 intervention

Group B: Sham acupuncture group (SA)Sham comparator 1 intervention

Group C: Waitlist control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline and 8 weeks

Secondary outcomes

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.

Time frame

Baseline and 8 weeks

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.

Time frame

Baseline and 8 weeks

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.

Time frame

Baseline and 8 weeks

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.

Time frame

Baseline and 8 weeks

Other outcomes

The number of participants with treatment-related adverse events recorded in Case Report Form(CRF) at the end of treatment at 8 weeks

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xi Wu

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Sponsor institution

Source ClinicalTrials.gov

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