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Study of Menstrual Migraine Prevention by Percutaneous Mastoid Electrical Stimulator: A multicenter, randomized, double blind, controlled trial

Study of Menstrual Migraine Prevention by Percutaneous Mastoid Electrical Stimulator: A multicenter,randomized, double blind, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019673
Enrollment
Unknown
Registered
2018-11-22
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-11-26

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

Conditions

migraine

Interventions

experimental group:Percutaneous mastoid electrical stimulator

Sponsors

The Second People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–55 years old; 2. Menstrual migraine (International Classification of Headache Disorders [ICHD]-II code 1.2.1 or 1.1); 3. The first migraine attack was before 50 years old; 4. The disease course longer than half a year; 5. At least 2 attacks every 3 menstruing cycles before inclusion; 6. Migraine attacks occur during the last menstrual period; 7. Regular menstrual cycles.

Exclusion criteria

Exclusion criteria: 1. use of a preventive antimigraine treatment such as beta blockers, calcium channel blockers, antiepileptic drugs, antidepressants and 5-HT receptor blockers in the previous 3 months; 2. failure on =3 well-conducted preventive drug treatments; 3. medication overuse headache (ICHD-II 8.2)(>10 days per month usage of preventive medication for migraine attacks); 4. alcohol abuse and/or other drug overuse; 5. severe neurological or psychiatric disorders; 6. Severe primary systemic disorders including heart, brain, liver, kidney, hematopoietic system; 7. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
change in monthly migraine days between the run-in month and the third month of treatment;percentage of of subjects having at least 50% reduction of monthly migraine days;

Secondary

MeasureTime frame
change in monthly migraine days between run-in and the average 3 months of treatment;change in mean headache severity per migraine day;change in monthly acute antimigrainedrug use;Change of the Headache Impact Test-6 questionnaire;

Countries

China

Contacts

Public ContactWang Jian

The Second People's Hospital of Chengdu

jianwangx@sina.com+86 13689061372

Outcome results

None listed

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