NCT00286923

Brief Summary

The purpose of the study is to determine by the use of non-invasive magnetic stimulation if the medication Topiramate adjusts the excitability of the migraine sufferer's brain. Previous studies have shown the migraine sufferer's brain is more excitable. The magnetic stimulation device has given us a way to look at excitability and to see if it changes at the same time that a headache diary shows if the pattern or severity of headaches changes with the administration of the drug Topiramate. It is expected that as migraine sufferers have fewer headaches with topiramate the testing with magnetic stimulation will show that their brains are less excitable and that if the topiramate does not change the character of headaches then the pattern of excitabilty would not change from the baseline test before medication is started.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 14, 2006

Status Verified

February 1, 2006

First QC Date

February 2, 2006

Last Update Submit

February 13, 2006

Conditions

MigraineChronic Headache

Keywords

migrainechronic headachehyperexcitabilityMagnetic stimulation

Interventions

TopiramateDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects 18 to 55 years old with migraine headaches as defined by the International Headache Society (IHS).
  • Subjects must be willing to take topiramate for migraine prophylaxis

You may not qualify if:

  • \. Subjects with frequent tension headaches 2. Subjects with ill-defined head pain 3. Unable to be weaned off other headache prophylaxis. 4. Requiring daily use of centrally-acting medications. 5. Pregnant, lactating and women not on adequate birth control measures. 6. Subjects with a personal or family history of seizures of any type. 7. History of head injury or brain surgery. 8. Cardiac pacemakers or any other implanted electronic device. 9. Subjects with history of headaches or with history of tension-type headaches recurring \>1/month and relieved by over the counter medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Headache Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (3)

  • Aurora SK, Barrodale P, Chronicle EP, Mulleners WM. Cortical inhibition is reduced in chronic and episodic migraine and demonstrates a spectrum of illness. Headache. 2005 May;45(5):546-52. doi: 10.1111/j.1526-4610.2005.05108.x.

    PMID: 15953273BACKGROUND

  • Aurora SK, Cao Y, Bowyer SM, Welch KM. The occipital cortex is hyperexcitable in migraine: experimental evidence. Headache. 1999 Jul-Aug;39(7):469-76. doi: 10.1046/j.1526-4610.1999.3907469.x.

    PMID: 11279929BACKGROUND

  • Aurora SK, Ahmad BK, Welch KM, Bhardhwaj P, Ramadan NM. Transcranial magnetic stimulation confirms hyperexcitability of occipital cortex in migraine. Neurology. 1998 Apr;50(4):1111-4. doi: 10.1212/wnl.50.4.1111.

    PMID: 9566403BACKGROUND

MeSH Terms

Conditions

Migraine DisordersHeadache Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Sheena K. Aurora, M.D.

    Emerald City Headache Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 6, 2006

Study Start

February 1, 2006

Study Completion

August 1, 2006

Last Updated

February 14, 2006

Record last verified: 2006-02

Locations

US(1)