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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Acupuncture
  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 week
• Другое Sham acupuncture
  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, bi

Первичные конечные точки

• Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]

Вторичные конечные точки (12)

• Changes of Digit Span Test scores from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Changes of Trail Making Test scores from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Changes of Stroop Test scores from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Change of Verbal Fluency Test Scores from baseline to the end of 8 weeks. [Срок оценки: Baseline and 8 weeks]
• Change of Boston Naming Test from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Change of Multidimensional Fatigue Inventory score from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Change of Pittsburgh Sleep Quality Index from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Change of the Generalized Anxiety Disorde-7 score from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Change of Hamilton Depression Scale from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]
• Change of the MOS Item Short From Health Survey from baseline to the end of 8 weeks [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Chengdu University of Traditional Chinese Medicine — Чэнду
• Chengdu University of Traditional Chinese Medicine — Чэнду

Публикации

• 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. PMID 42383026

Идентификаторы

NCT: NCT07357688 · 2025KL-111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗