Migraine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Fulfills the diagnostic criteria for migraine without aura according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) , and meets the TCM diagnostic criteria (with reference to the 2017 edition of the Criteria for Diagnosis and Therapeutic Effect of TCM Diseases and Syndromes). (2) Aged 18–65 years, right-handed. (3) History of migraine with a frequency of =2 attacks per month and =2 attacks per week within the past 3 months. (4) Has not received prophylactic medication for migraine, or has completed a washout period of =4 weeks. (5) Voluntarily participates in the study and provides written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with other types of headache or secondary headache attributed to epilepsy, cerebrovascular disease, or intracranial space-occupying lesions. (2) Patients with a history of severe cardiac, hepatic, or renal disease, or psychiatric disorders. (3) Patients with a history of craniocerebral surgery, non-MRI-compatible metallic implants, severe claustrophobia, or any other condition that precludes completion of cranial MRI examination. (4) Pregnant or lactating women. (5) Patients who have participated in other clinical studies within the recent period (e.g., within 3 months or 1 month). (6) Any other conditions that the investigator deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate (=50% reduction in MMD from baseline); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change headache pain intensity;Migraine attack frequency;Headache duration;Acute medication use;Migraine-related disability;Overall impact of headache on functional health;Migraine-specific quality of life;Migraine-related functional impairment;Depression severity;Anxiety severity;Sleep quality;Traditional Chinese Medicine symptom improvement;Patient satisfaction;Electroencephalography power spectrum changes; Event-Related Potentials (ERPs);Electroencephalography microstate parameter changes;Brain morphological changes ;Changes in white matter microstructural integrity;Cerebral blood flow changes;Resting-state brain activity and functional connectivity changes; | — |
Countries
China
Contacts
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences