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Study of Migraine Prevention by Electrical Stimulation of both Mastoids behind the ears: A multicenter,randomized, double blinded controlled trial

Study of Migraine Prevention by Electrical cerebellar fastigial nucleus stimulation: A multicenter,randomized, double blinded controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ICR-15006273
Enrollment
Unknown
Registered
2015-04-05
Start date
2013-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

migraine

Interventions

experimental group:electrical stimulation of both mastoids behind the ears

Sponsors

the Second People's Hospital of Chengdu, Chengdu, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years old; 2. migraine with or without aura (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 1 year; 5. at least 2 attacks per month.

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; 8. Allergic to study drug.

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 monthly migraine attack frequency;change in mean headache severity per migraine day;change in monthly acute antimigrainedrug use;Change of the Migraine Disability Assessment questionnaire;

Countries

China

Contacts

Public ContactWang Jian
jian.wx@163.com+86 13789063972

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026