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Clinical effectiveness of fastigial nucleus electrical stimulation in chronic migraine and a functional MRA study

EClinical effectiveness of fastigial nucleus electrical stimulation in chronic migraine and a functional MRA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106618
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-07-28
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Migraine

Interventions

Control group:sham stimulation treatment
FNS treatment group:FNS group
control group(health group):None

Sponsors

Second people's hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 18-50 years old; According to the third edition of Headache Classification and Diagnostic Criteria (ICDH-3) published by the International Headache Society, the diagnostic requirements for chronic migraine are: >=15 days/month of headache, lasting at least 3 months, of which at least 8 days per month of headache meet the diagnostic criteria for migraine or migraine specific drugs are effective.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients with special types of migraine, such as ophthalmoplegic migraine, hemiplegic migraine, etc. Have received preventive migraine treatment in the past 3 months; Have used at least 3 preventive medications; Patients with secondary headache; Those undergoing hormone therapy; Some characteristic groups such as pregnant women, nursing patients, drug users, etc.; Serious organic or mental illness; MRI contraindications.

Design outcomes

Primary

MeasureTime frame
Compared with baseline, change in headache days at month 3; ;50% response rate, that is, a reduction of >=50% in headache days at month 3 compared to baseline;

Secondary

MeasureTime frame
fMRI;BOLD-fMRI;Compared with baseline, Change in mean monthly headache days during the 3-month treatment period;Changes in headache frequency during the 3rd month;Changes in the frequency of any headaches during the third month;Change in headache severity at month 3;The proportion of analgesics used and the frequency of taking analgesics in the third month;MIDAS score change;Patient satisfaction with treatment at the end of the third month of the trial;FNSVitamin D levels;Leukocyte count;Neutrophil count;C-reactive protein;HAMD;HAMA;The HAMD changed after FNS treatment;Differences in functional magnetic resonance imaging between the normal group and the chronic migraine group;The HAMA changed after FNS treatment;

Countries

China

Contacts

Public ContactLanying He

Second people's hospital of Chengdu

531324679@qq.com+86 151 0826 7609

Outcome results

None listed

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