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fMRI-Based Investigation into the Remodeling Mechanism of Brain Functional Networks by Meridian Sinew Intervention in Insomnia Patients

fMRI-Based Investigation into the Remodeling Mechanism of Brain Functional Networks by Meridian Sinew Intervention in Insomnia Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000445
Enrollment
Unknown
Registered
2026-03-03
Start date
2025-08-31
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Insomnia

Interventions

Control group:No intervention
Insomnia medication treatment group:Drug treatment
Insomnia Meridian Sinew Therapy Group:Meridian Sinew Therapy

Sponsors

The Second Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Meeting the diagnostic criteria for Chronic Insomnia Disorder (CID) as defined in the International Classification of Sleep Disorders, 3rd Edition (ICSD-3); presenting chief complaints of difficulty initiating or maintaining sleep, with persistent insomnia despite adequate sleep duration and appropriate sleep environment, accompanied by impaired daytime functioning; with symptoms lasting for more than 3 months and occurring at least 3 times per week. 2.The Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) indicate the presence of cognitive impairment. The diagnostic criteria for Mild Cognitive Impairment (MCI) are as follows: (1) Evidence of memory decline that affects the maintenance of daily activities; (2) Scores on the MoCA and MMSE scales of 6 years but 12 years of education, no points will be added to the total score. 3. Right-handed; 4. Aged 20–60 years; 5. No history of psychiatric or neurological disorders; 6. No history of addiction to drugs, alcohol, or tobacco.

Exclusion criteria

Exclusion criteria: 1.Having contraindications to magnetic resonance imaging (MRI) scans; 2.Suffering from intracranial organic/tumorous lesions or severe somatic diseases; 3. With a family history of genetic diseases or psychiatric disorders; 4. Females who are pregnant, lactating or menstruating; 5. Being unable to tolerate Meridian Sinew Therapy.

Design outcomes

Primary

MeasureTime frame
Neuroimaging parameters [quantitative indicators of brain metabolites (Glu, GABA, NAA, etc.), dynamic connectivity parameters of brain networks (fractional windows, transition counts, transition probabilities, etc.)];

Secondary

MeasureTime frame
Sleep function-related scales (such as PSQI, ISI, ESS, etc.);

Countries

China

Contacts

Public ContactGengbiao Zhang

The Second Affiliated Hospital of Shantou University Medical College

781249852@qq.com13670499224

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026