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Investigating the Brain-Gut Regulatory Mechanism in Elderly Patients with Chronic Fatigue Syndrome Treated with Tongdu Yubi Diao Shen Acupuncture Method Based on Multimodal MRI Combined with Gut Microbiota.

Investigating the Brain-Gut Regulatory Mechanism in Elderly Patients with Chronic Fatigue Syndrome Treated with Tongdu Yubi Diao Shen Acupuncture Method Based on Multimodal MRI Combined with Gut Microbiota.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000057
Enrollment
Unknown
Registered
2026-01-13
Start date
2025-10-30
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Interventions

Needle Retention Group:Filiform needles are used for acupuncture, with the even reinforcing-reducing manipulation applied. After Deqi (the arrival of qi) is achieved, no additional operations are perf
Needle Twisting Group:Filiform needles are used for acupuncture, with the even reinforcing-reducing manipulation applied. After Deqi (the arrival of qi) is achieved, the head acupoints including Baihu
the intensity is adjusted to the maximum tolerance of the patient. The total needle retention time is 30 minutes, and during this period, needle manipulation is performed once every 10 minutes. For th
Group with 2 Hz:Acupuncture is performed with filiform needles, using the even reinforcing-reducing manipulation. After deqi (the arrival of qi) is achieved, the acupoints are divided into two groups
Group with 10 Hz:The operation method is the same as that of the 2 Hz gr

Sponsors

Affiliated TCM Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 70 Years

Inclusion criteria

Inclusion criteria: Preliminary Screening and Inclusion Criteria for Clinical Enrollment Preliminary Screening Criteria for Clinical Enrollment: (1) Informed consent provided by the subjects;(2) Aged 60–70 years, regardless of gender, and right-handed;(3) No dementia, and not meeting the dementia diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV);(4) No history of neuropsychiatric diseases (e.g., cerebrovascular disease, epilepsy, Parkinson's disease, multiple sclerosis, encephalitis, depression, schizophrenia, substance dependence, intracranial tumors, craniocerebral trauma surgery, etc.), and no severe diseases of the heart, liver, kidneys, hematopoietic system, or endocrine system that significantly impair cognitive function;(5) Visual and auditory abilities sufficient to meet the requirements of cognitive assessment;(6) No implanted metal or electronic devices. Inclusion Criteria for the Treatment Group: (1) Meeting the above two diagnostic criteria;(2) Primarily presenting with memory impairment or difficulty concentrating, with other cognitive functions relatively intact or mildly impaired;(3) Montreal Cognitive Assessment (MoCA) score < 26;(4) No disease-related treatment received at least 30 days prior to the start of treatment;(5) Clear consciousness, no intellectual disability, stable mood, and ability to cooperate with doctors for diagnosis and treatment;(6) Discontinuation of other treatments that may affect the efficacy evaluation of this study during the trial period. Inclusion Criteria for the Healthy Group: (1) No complaints of cognitive impairment;(2) No functional or organic diseases detected through physical examination;(3) Montreal Cognitive Assessment (MoCA) score = 26, and all results of multidimensional cognitive neuropsychological assessment fall within the normal range corresponding to the subject's age or educational level;(4) No medication taken and no participation in other clinical studies at least 30 days prior to entering the study. Subjects must meet all the above criteria specific to their respective groups to be enrolled.

Exclusion criteria

Exclusion criteria: (1) Those with a history of cerebrovascular diseases, brain parenchymal lesions, and head trauma; (2) Those with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic systems; (3) Those with progressive malignant tumors or other severe wasting diseases, prone to infections and bleeding; (4) Those with contraindications for MRI examination or claustrophobia; (5) Those who have recently participated in other drug clinical trials. If any one of the above exclusion criteria is met, the subject is not eligible for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Clinical Scale Evaluation;

Secondary

MeasureTime frame
Multimodal MRI Data;16S rDNA Sequencing Analysis and Non-targeted Metabolomics Analysis of Feces;

Countries

China

Contacts

Public ContactYangTiansong

Affiliated TCM Hospital of Guangzhou Medical University

958218699@qq.com18846178111

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026