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Study on the spatiotemporal brain network regulation mechanism and efficacy prediction of acupuncture treatment for comorbid depression in migraines based on Granger causality

Study on the spatiotemporal brain network regulation mechanism and efficacy prediction of acupuncture treatment for comorbid depression in chronic migraines based on Granger causality

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088834
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-03-10
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

migraine

Interventions

experimental group: acupuncture
control group:Venlafaxine hydrochloride sustained-release tablets

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine/ Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Migraine without aura comorbid with depression in subjects 1. Age range between 18 and 55 years old (initial onset age less than 50 years old), regardless of gender; 2. Right-handed, with a minimum of 6 years of compulsory education; 3. Meets the diagnostic criteria for migraine without aura according to ICHD-3; 4. The number of episodes per month in the past three months is greater than or equal to 2, and the number of headache days per month is less than 15 days; 5. At baseline, patients may experience moderate to severe headaches (with an average VAS score of = 5); 6. Have a history of migraine for more than one year; 7. Not taking any psychotropic drugs in the past 3 months; 8. Not taking any vasoactive drugs in the past 2 weeks; 9. The Hamilton Anxiety Scale (HAMA)/Hamilton Depression Scale 17 items (HAMD-17) were rated as mild to moderate anxiety/depression. (Only patients who meet the above 9 criteria can be included in this study.) Healthy controls 1. Right handed, gender not limited; 2. Age between 18 and 55 years old, with at least 6 years of education; 3. Medical history investigation and routine physical examination results indicate good physical health; 4. I have signed the informed consent form. Only patients who meet the above four criteria can be included in this study

Exclusion criteria

Exclusion criteria: Migraine without aura comorbid with depression in subjects 1. The first onset of migraine occurs after the age of 50; 2. Concomitant history of head injury, secondary headache, tension type headache, intermittent headache, cluster headache Waiting for patients; 3. Patients with serious primary diseases such as hypertension, high cholesterol, diabetes, cardiovascular disease, etc; 4. Individuals who are prone to concurrent infections and bleeding, and those with allergic constitution; 5. Pregnant and lactating women; 6. Individuals with severe anxiety and depression; 7. Individuals with metal implants in their bodies and contraindications for MRI examinations such as claustrophobia; 8. Severe anatomical asymmetry or clear lesions of the head were found in MRI scans. (Anyone who meets any of the above criteria should be excluded.) Healthy controls 1. Patients with serious primary diseases such as hypertension, high cholesterol, diabetes, cardiovascular disease, etc; 2. Patients with mental illness, those prone to co infection and bleeding, and those with allergies; 3. Drug, alcohol, coffee and other abuse/dependence habits; 4. Pregnant and lactating women; 5. Individuals with contraindications for MRI examinations such as claustrophobia; 6. Severe head anatomical asymmetry or clear lesions were found in MRI scans.

Design outcomes

Primary

MeasureTime frame
Treatment effectiveness (response rate);fMRI;

Secondary

MeasureTime frame
Hamilton anxiety scale (HAMA);Hamilton Depression Scale (HAMD-17);Days of migraine attack;Frequency of migraine attacks;Intensity of migraine;Montreal Cognitive Assessment Scale Basic Version (MoCA-B);Migraine Specific Quality of Life Question, MSQ;Headache impact scale (HIT-6);Percentage of patients taking acute analgesic;

Countries

China

Contacts

Public ContactXiao Wang

Chengdu University of Traditional Chinese Medicine

wangxiao2@cdutcm.edu.cn+86 187 8014 1151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026